MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05,06,07 report with the FDA on 2011-08-02 for TOTAL PROTEIN GEN.2 03183734190 manufactured by Roche Diagnostics.
[9399382]
A specific root cause could not be determined. According to the information provided, the customer believes that the sample aliquot cup may have been reused and may have been contaminated with another sample. Good laboratory practice is essential to generate plausible patient results. No adverse events were reported.
Patient Sequence No: 1, Text Type: N, H10
[18411291]
A regional application specialist was notified that a customer received questionable results for one patient sample involving multiple assays. The assays that were erroneous and were reported outside the laboratory were glucose, creatinine and total protein. All testing was performed on a cobas 6000 c501 analyzer, serial number (b)(4). The initial total protein result was 9. 1 g/dl and was reported outside the laboratory. The operator questioned the results of a different assay generated from this sample and pulled the sample to repeat it. The repeat result was 7. 7 g/dl and was also reported outside the laboratory in a corrected report. The patient was not treated or harmed based on the erroneous result. The customer believed the sample cup was not properly discarded by the operator after use and may have been contaminated by another sample. She coached the appropriate personnel to avoid future issues. The regional application specialist did not determine the cause of the discrepancies. She concluded it was possible that the patient sample was pipetted into an already used cup. She advised the customer to toss all the cups after use.
Patient Sequence No: 1, Text Type: D, B5
[18739093]
Other assays related to this event are reported in medwatch reports patient identifiers: (b)(6).
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 1823260-2011-04133 |
| MDR Report Key | 2186515 |
| Report Source | 05,06,07 |
| Date Received | 2011-08-02 |
| Date of Report | 2011-08-23 |
| Date of Event | 2011-07-21 |
| Date Mfgr Received | 2011-07-21 |
| Date Added to Maude | 2011-08-02 |
| 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 | 2011-08-02 |
| Model Number | NA |
| Catalog Number | 03183734190 |
| Lot Number | 63870401 |
| ID Number | NA |
| Device Expiration Date | 2012-05-31 |
| 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 | 2011-08-02 |