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 2017-06-13 for COBAS 8000 C 702 MODULE C702 06473245001 manufactured by Roche Diagnostics.
[77641891]
This event occurred in (b)(6).
Patient Sequence No: 1, Text Type: N, H10
[77641892]
The customer stated that they received erroneous results for three patient samples tested for bilt3 bilirubin total gen. 3 (tbil) on a cobas 8000 c 702 module (c702). Of the three samples, one had an erroneous result that was reported outside of the laboratory. The sample initially resulted as 0 umol/l and this value was automatically released to the lis and the requesting doctor. The doctor realized that the result was erroneous and requested repeat testing. The repeat result was 236. 7 umol/l and this value was reported outside of the laboratory. No adverse events were alleged to have occurred with the patient. The tbil reagent lot number was 201416. The reagent expiration date was asked for, but not provided. Tbil calibrations are performed daily and have been very steady. Erroneous low results for the two other patient samples were found by the customer on (b)(6) 2017. While investigating this occasion, the field service engineer found that the customer was running the samples in the same rack in micro-cups on top of false bottom tubes. The engineer also found that the sample probe was dirty, possibly with gel. He replaced the probe and re-aligned it.
Patient Sequence No: 1, Text Type: D, B5
[120146859]
The analyzer sample probe was unusually contaminated above the tip. The probe also was misadjusted. Investigations conclude that the misalignment of the sample probe caused contamination of the probe, leading to the event.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 1823260-2017-01228 |
| MDR Report Key | 6637788 |
| Report Source | FOREIGN,HEALTH PROFESSIONAL,U |
| Date Received | 2017-06-13 |
| Date of Report | 2017-07-18 |
| Date of Event | 2017-05-21 |
| Date Mfgr Received | 2017-05-30 |
| Date Added to Maude | 2017-06-13 |
| 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 |
| Reporter Occupation | OTHER HEALTH CARE PROFESSIONAL |
| 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 C 702 MODULE |
| Generic Name | CLINICAL CHEMISTRY ANALYZER |
| Product Code | MQM |
| Date Received | 2017-06-13 |
| Model Number | C702 |
| Catalog Number | 06473245001 |
| 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 C 702 MODULE |
| Generic Name | CLINICAL CHEMISTRY ANALYZER |
| Product Code | JJE |
| Date Received | 2017-06-13 |
| Model Number | C702 |
| Catalog Number | 06473245001 |
| 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 | 2017-06-13 |