MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2019-05-21 for ROCHE COBAS CHEMISTRY ANALYZER ROCHE COBAS 8000 COBAS C 702 manufactured by Roche Diagnostics Operations Inc..
[146056254]
Wrong results of creatinine, ast, albumin, calcium and other tests were generated by roche cobas 8000 analyzers in our lab. The system did not give us any warnings or alerts. A creatinine of 0. 35 was reported on a pt with renal disease. The nurse called questioning the result. Upon repeat, creatinine became 2. 18. After the nurse called, we started to look at other pts and other results and found multiple pts were affected. We discovered that there was a problem with the analyzer. This kind of problem happened several times in the past to us. Our concern is that the cobas chemistry analyzers do not have sufficient warning mechanisms to alert operators with machine problems. Users can report erroneous results to other healthcare providers unknowingly. This particular pt had end stage renal failure and received kidney transplant two weeks ago. A creatinine of 0. 35 was too good to be true for this pt. That was why the nurse called. We also placed other criteria in the computer which allowed us to find wrong albumin results which were higher than total protein. Fda safety report id# (b)(4).
Patient Sequence No: 1, Text Type: D, B5
| Report Number | MW5086813 |
| MDR Report Key | 8632059 |
| Date Received | 2019-05-21 |
| Date of Report | 2019-05-17 |
| Date of Event | 2019-05-17 |
| Date Added to Maude | 2019-05-22 |
| Event Key | 0 |
| Report Source Code | Voluntary report |
| Manufacturer Link | N |
| 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 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 0 |
| Brand Name | ROCHE COBAS CHEMISTRY ANALYZER |
| Generic Name | ANALYZER CHEMISTRY PHOTOMETRIC DISCRETE FOR CLINICAL USE |
| Product Code | JJE |
| Date Received | 2019-05-21 |
| Model Number | ROCHE COBAS 8000 |
| Catalog Number | COBAS C 702 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Eval'ed by Mfgr | I |
| Device Sequence No | 0 |
| Device Event Key | 0 |
| Manufacturer | ROCHE DIAGNOSTICS OPERATIONS INC. |
| Manufacturer Address | INDIANAPOLIS IN 46256 US 46256 |
| Brand Name | ROCHE COBAS CHEMISTRY ANALYZER |
| Generic Name | ALBUMIN, ANTIGEN, ANTISERUM, CONTROL |
| Product Code | DCF |
| Date Received | 2019-05-21 |
| Model Number | ROCHE COBAS 8000 |
| Catalog Number | COBAS C 702 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Eval'ed by Mfgr | I |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | ROCHE DIAGNOSTICS CORP. |
| Manufacturer Address | INDIANAPOLIS IN 46256 US 46256 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2019-05-21 |