MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2017-07-19 for COBAS 8000 C 502 MODULE 5964067001 manufactured by Roche Diagnostics Gmbh.
[80449810]
Patient Sequence No: 1, Text Type: N, H10
[80449811]
We noticed a sporadic quality control problem for urine microalbumin and also urine total protein. We ran a precision study and it failed. We called service and they found a failing "gear pump" which rinses out the sample pipette (its failure was intermittent). When it failed, it did not rinse serum out of the pipette, and it affected urine tests since there is 1000 times as much protein in serum as in urine. The pump is replaced every three years on a schedule, but this one was replaced a year ago, so it failed much sooner than anticipated. Additionally, this is not an item the lab staff can access. After the repair, we looked back and pulled 150 samples run since the problem appears to have begun. We repeated all of the testing and found 21 samples had been reported in error. All were falsely elevated (i. E. False positives). We made corrected reports and notified the physicians.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 6724558 |
| MDR Report Key | 6724558 |
| Date Received | 2017-07-19 |
| Date of Report | 2017-07-11 |
| Date of Event | 2017-06-23 |
| Report Date | 2017-07-11 |
| Date Reported to FDA | 2017-07-11 |
| Date Reported to Mfgr | 2017-07-11 |
| Date Added to Maude | 2017-07-19 |
| Event Key | 0 |
| Report Source Code | User Facility report |
| Manufacturer Link | N |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 3 |
| 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 | 3 |
| Brand Name | COBAS 8000 C 502 MODULE |
| Generic Name | ALBUMIN IMMUNOLOGICAL TEST SYSTEM |
| Product Code | DCF |
| Date Received | 2017-07-19 |
| Model Number | 5964067001 |
| Catalog Number | 5964067001 |
| Device Availability | Y |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | ROCHE DIAGNOSTICS GMBH |
| Manufacturer Address | 9115 HAGUE RD. INDIANAPOLIS IN 46250 US 46250 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2017-07-19 |