MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05,06 report with the FDA on 2011-06-28 for TOTAL PROTEIN 12000903216 manufactured by Roche Diagnostics.
[17410613]
The user received a questionable total protein result for one patient sample from the analytical p module analyzer serial number (b)(4). The initial result from an aliquot of the sample was 11. 8 g/dl and was reported outside the laboratory. The original sample was repeated and the result was 6. 6 g/dl. The aliquot was then repeated and the result was 6. 6 g/dl. The reported result was corrected on (b)(6) 2011. The user did not have access to information concerning if the patient was adversely affected. The total protein r2 reagent lot number was 63554801. Upon evaluation of the analyzer, the field service representative could not determine a cause. He checked multiple areas of the analyzer and all were acceptable. To verify the analyzer operation, he ran precision testing on the total protein assay.
Patient Sequence No: 1, Text Type: D, B5
[17656419]
.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 1823260-2011-03499 |
| MDR Report Key | 2143257 |
| Report Source | 05,06 |
| Date Received | 2011-06-28 |
| Date of Report | 2011-06-28 |
| Date of Event | 2011-06-14 |
| Date Mfgr Received | 2011-06-15 |
| Date Added to Maude | 2011-06-28 |
| 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 |
| Generic Name | BIURET (COLORIMETRIC), TOTAL PROTEIN |
| Product Code | CEK |
| Date Received | 2011-06-28 |
| Model Number | NA |
| Catalog Number | 12000903216 |
| Lot Number | 63476401 |
| ID Number | NA |
| Device Expiration Date | 2012-02-29 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| 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 | 2011-06-28 |