MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a health professional,user faci report with the FDA on 2016-10-17 for COBAS 6000 C501 MODULE 05860636001 manufactured by Roche Diagnostics.
[57629412]
(b)(4).
Patient Sequence No: 1, Text Type: N, H10
[57629413]
The customer complained of an erroneous high result for 1 patient tested for nh3l ammonia (nh3l). The erroneous result was reported outside of the laboratory. The initial nh3l result was 610. 0 umol/l from the c501 analyzer. This result was reported outside of the laboratory where the doctor questioned it. A second sample was obtained and the result from a second c501 analyzer was 83. 3 umol/l. The initial sample was repeated on the first c501 analyzer even though it was no longer on ice and the result was 76. 7 umol/l. The initial sample was also repeated on the second c501 analyzer and the result was 71 umol/l. No adverse event occurred. The nh3l reagent lot number was 12955701 with an expiration date of 07/31/2017. The customer replaced the reaction cells before the event on (b)(6) 2016 and after the event on (b)(6) 2016. The field service engineer (fse) visited the customer site and checked multiple parts of the analyzer. Vacuum pump diaphragms were also checked and replaced even though they were not worn through. All analyzer specifications were within the appropriate guidelines and no adjustments were required. The fse ran precision tests and repeated the original sample in question 5 times. The results were repeated with no erroneous high results. Quality controls (qc) were acceptable and the customer began to run patient samples again. A specific root cause could not be identified. Additional information was requested for investigation, but was not provided. Based on the information available for investigation, an instrument and reagent issue can be excluded since calibration and qc were acceptable. The instrument was also checked by the fse and no issues were identified. Based on a review of the reaction monitor, the most likely root cause is a carry-over issue because the reaction curve provided for the initial result decreased abnormally.
Patient Sequence No: 1, Text Type: D, B5
[59164933]
The customer has not had any further issues since the reaction cells were replaced on (b)(6) 2016 and the service visit by the fse.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 1823260-2016-01581 |
| MDR Report Key | 6033650 |
| Report Source | HEALTH PROFESSIONAL,USER FACI |
| Date Received | 2016-10-17 |
| Date of Report | 2016-11-01 |
| Date of Event | 2016-09-30 |
| Date Mfgr Received | 2016-09-30 |
| Date Added to Maude | 2016-10-17 |
| 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 6000 C501 MODULE |
| Generic Name | CLINICAL CHEMISTRY ANALYZER |
| Product Code | JIF |
| Date Received | 2016-10-17 |
| Model Number | C501 |
| Catalog Number | 05860636001 |
| 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 6000 C501 MODULE |
| Generic Name | CLINICAL CHEMISTRY ANALYZER |
| Product Code | JJE |
| Date Received | 2016-10-17 |
| Model Number | C501 |
| Catalog Number | 05860636001 |
| 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 | 2016-10-17 |