MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a foreign,health professional,u report with the FDA on 2017-03-21 for COBAS 8000 E 602 MODULE E602 05990378001 manufactured by Roche Diagnostics.
[70425219]
This event occurred in (b)(6). (b)(4).
Patient Sequence No: 1, Text Type: N, H10
[70425220]
The customer stated that they received an erroneous result for one patient sample tested for the elecsys testosterone ii assay (testo) on a cobas 8000 e 602 module (e602). All results from the sample were reported outside of the laboratory. The sample initially resulted as 9. 14 nmol/l. The sample was repeated twice on (b)(6) 2017, resulting as 0. 869 nmol/l and 9. 45 nmol/l. It was not known which result was correct, so the sample was sent to be verified using a mass spectrophotometry method. When tested with the mass spectrophotometry method, the sample resulted as 9. 7 nmol/l, confirming the higher value of the patient sample. There were no allegations of any adverse events to the patient. The reagent lot number was 19105300. The expiration date was requested but not provided. Subsequent control recovery on one channel (channel 2) of the analyzer was found to be poor, so the module was masked for further testing and samples were being repeated to check for any further issues. No further patient data was provided. It was noted that the control units of the analyzer have been replaced more than once recently and multiple issues had been occurring with the analyzer. The field service engineer ran performance testing on the analyzer and noticed that measuring cell carryover increased. He re-aligned the sipper line, checking for any contamination. No contamination could be found. He visually checked the measuring cell and flushed it manually; no obvious issues were seen. He replaced the sipper syringe assembly and replaced a printed circuit board. He repeated performance testing and all was ok except for recovery on channel 1. The carryover issue with the original performance testing was corrected. He repeated performance testing on channel 1 and this was ok on second attempt. Calibrations and controls were tested and all were ok. On (b)(6) 2017, it was stated that the customer noticed a drift in control recovery, especially on measuring cell 2. It was stated that the measuring cells were replaced twice. It was stated that a cell was replaced on (b)(6) 2017. The whole detection units were changed as well, along with a mixer and reagent pipettor. All sampling positions and valves were checked for reagent delivery. The customer noted that they had had a sipper probe movement error on the night of (b)(6) 2017. The customer could see bubbles in reagent cups. The customer has stopped running the instrument for patient tests and are periodically running quality controls to monitor the situation.
Patient Sequence No: 1, Text Type: D, B5
[75257630]
A specific root cause could not be determined based on the provided information. Root causes include reagent or sample pipetting issues. Since reagent pipetting was from the same reagent pack, a reagent specific issue is unlikely. The observed control issues indicate an issue with reagent microparticle capture, which may possibly be caused by issues with sample quality. Performance testing confirmed that the analyzer was working within specification and no further issues have been reported by the customer.
Patient Sequence No: 1, Text Type: N, H10
[96517079]
The customer reported that they had further issues on (b)(6) 2017. Quality controls were extremely low for the elecsys troponin t (tnt) assay and digoxin assay. The customer also stated that they had erroneous results for two patient samples tested for tnt. The erroneous results were not reported outside of the laboratory. No adverse events were alleged to have occurred with the patients. The first sample initially resulted as 24 mg/l and repeated as 50 mg/l. The second sample initially resulted as 19 mg/l and repeated as 32 mg/l. The field service engineer ran performance testing and some test values were blank after two attempts. It was noted that quality controls value shifted intermittently and there would be as much as a 50% difference between subsequent control values. The field service engineer returned to the site and replaced a nozzle, a nozzle seal, and a sample syringe seal. He cleaned probes and cleaned a fluidic line with fishing wire. He cleaned a valve and syringe filters. Everything appeared to be ok, there was no contamination or blockage. He ran performance testing, but some parameters failed.
Patient Sequence No: 1, Text Type: N, H10
[120550506]
The customer stated that quality controls for multiple assays have shifted on one channel of the analyzer. Upon repeat, controls shift back. A new performance test was run on the analyzer with low, erratic values.
Patient Sequence No: 1, Text Type: N, H10
[132587093]
The customer stated that they are still having problems with the analyzer. Multiple assays were out of range for proficiency survey samples that were tested. The customer states that they are having to calibrate more frequently in order to keep quality controls within range. Controls can be run one day and be out of range on the next day. The customer has been repeating testing every 2 hours in order to detect any shifts. Over the past months, the second analyzer measuring cell generally performs worse than the first measuring cell. Controls for multiple tests run on a roche cobas 8000 clinical chemistry analyzer on the same line have also had poor recovery. A contamination in the entire line of analyzers is suspected.
Patient Sequence No: 1, Text Type: N, H10
[132589027]
Extensive troubleshooting was performed on the analyzer. In summary, control shifts were observed on the analyzer after being rebooted. The shift issue indicated an issue with a printed circuit board. This was solved after replacement of the printed circuit board.
Patient Sequence No: 1, Text Type: N, H10
[132589289]
On (b)(4) 2017, system reagents were reset in the analyzer software before rebooting the analyzer. A cup/tip magazine alarm occurred after rebooting the analyzer. On (b)(4) 2017, there were sample short alarms and alarms indicating low system reagent volume on another module on the same line. Controls for several assays shifted on multiple analyzers, including the affected e602 analyzer. Shifts seen on the modules were believed to occur after resets that were done after receiving low system reagent volume errors. For the affected e602 analyzer, the control shift occurred after a reboot in the morning of (b)(4) 2017. An alarm occurred after the reboot. The analyzer was rebooted again before running controls.
Patient Sequence No: 1, Text Type: N, H10
[132589650]
The issue was determined to be an electronics issue. No further issues occurred after replacement of the printed circuit board.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 1823260-2017-00594 |
| MDR Report Key | 6420227 |
| Report Source | FOREIGN,HEALTH PROFESSIONAL,U |
| Date Received | 2017-03-21 |
| Date of Report | 2017-12-17 |
| Date of Event | 2017-02-21 |
| Date Mfgr Received | 2017-02-27 |
| Date Added to Maude | 2017-03-21 |
| Event Key | 0 |
| Report Source Code | Manufacturer report |
| Manufacturer Link | Y |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 0 |
| Product Problem Flag | 3 |
| Reprocessed and Reused Flag | 3 |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Manufacturer Contact | NA MICHAEL LESLIE |
| Manufacturer Street | 9115 HAGUE ROAD NA |
| Manufacturer City | INDIANAPOLIS IN 46250 |
| Manufacturer Country | US |
| Manufacturer Postal | 46250 |
| Manufacturer Phone | 3175214343 |
| Manufacturer G1 | HITACHI HIGH TECH CORP. |
| Manufacturer Street | 882 ICHIGE HITACHINAKA NA |
| Manufacturer City | IBARAKI 312-8504 |
| Manufacturer Country | JA |
| Manufacturer Postal Code | 312-8504 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Removal Correction Number | NA |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | COBAS 8000 E 602 MODULE |
| Generic Name | IMMUNOCHEMISTRY ANALYZER |
| Product Code | CDZ |
| Date Received | 2017-03-21 |
| Model Number | E602 |
| Catalog Number | 05990378001 |
| Lot Number | NA |
| ID Number | NA |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Age | DA |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 0 |
| Device Event Key | 0 |
| Manufacturer | ROCHE DIAGNOSTICS |
| Manufacturer Address | 9115 HAGUE ROAD NA INDIANAPOLIS IN 462500457 US 462500457 |
| Brand Name | COBAS 8000 E 602 MODULE |
| Generic Name | IMMUNOCHEMISTRY ANALYZER |
| Product Code | JJE |
| Date Received | 2017-03-21 |
| Model Number | E602 |
| Catalog Number | 05990378001 |
| Lot Number | NA |
| ID Number | NA |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Age | DA |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | ROCHE DIAGNOSTICS |
| Manufacturer Address | 9115 HAGUE ROAD NA INDIANAPOLIS IN 462500457 US 462500457 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2017-03-21 |