MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05,06 report with the FDA on 2011-08-01 for TOTAL PROTEIN GEN.2 03183734190 manufactured by Roche Diagnostics.
[9400125]
A specific root cause could not be determined. It was noted the issue has not reoccurred since the user began discarding the cups and stopped reusing empty cups. Good laboratory practice is essential to the generation of plausible patient results. None of the patients was adversely affected in this case.
Patient Sequence No: 1, Text Type: N, H10
[16105008]
The user received questionable results for two patient samples that had been aliquoted by the mpa (modular preanalytic analyzer) then tested on the cobas c501 analyzer serial number (b)(4). Data was provided for one patient sample whose results were discrepant and reported outside the laboratory. The initial total protein result was 5. 8 g/dl and the repeat result from the primary tube was 7. 5 g/dl. The patient was not admitted to a medical facility; treatment was not provided, altered or withheld due to the erroneous results that were reported out. The user declined a service visit and stated she would monitor the situation. The user stated they were told not to reuse the empty cups left in the racks after processing by the mpa, but they decided to check the cups and if they looked empty, then they would reuse the cups. They have discontinued reusing empty cups that were left in the racks and have not experienced a reoccurrence of the issue.
Patient Sequence No: 1, Text Type: D, B5
[16333422]
Other assays related to this event are reported in medwatch reports with patient identifiers: (b)(6).
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 1823260-2011-04117 |
| MDR Report Key | 2185818 |
| Report Source | 05,06 |
| Date Received | 2011-08-01 |
| Date of Report | 2011-08-31 |
| Date of Event | 2011-07-19 |
| Date Mfgr Received | 2011-07-20 |
| Date Added to Maude | 2011-08-01 |
| Event Key | 0 |
| Report Source Code | Manufacturer report |
| Manufacturer Link | Y |
| 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 | 0 |
| Event Location | 3 |
| Manufacturer Contact | NA JENNIFER WOLFGRAM |
| Manufacturer Street | 9115 HAGUE ROAD NA |
| Manufacturer City | INDIANAPOLIS IN 46250 |
| Manufacturer Country | US |
| Manufacturer Postal | 46250 |
| Manufacturer Phone | 3175217008 |
| Manufacturer G1 | ROCHE DIAGNOSTICS GMBH |
| Manufacturer Street | SANDHOFERSTRASSE 116 NA |
| Manufacturer City | MANNHEIM (BADEN-WURTTEMBERG) 68305 |
| Manufacturer Postal Code | 68305 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Removal Correction Number | NA |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | TOTAL PROTEIN GEN.2 |
| Generic Name | BIURET (COLORIMETRIC), TOTAL PROTEIN |
| Product Code | CEK |
| Date Received | 2011-08-01 |
| Model Number | NA |
| Catalog Number | 03183734190 |
| Lot Number | ASKU |
| ID Number | NA |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| 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 46250 US 46250 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2011-08-01 |