MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05,06 report with the FDA on 2011-06-17 for TOTAL PROTEIN GEN.2 03183734190 manufactured by Roche Diagnostics.
[2037000]
The user experienced calibration errors and flagged results for patient samples from the integra 800 analyzer serial number (b)(4). The user repeated testing of the patient samples on the other integra 800 analyzer serial number (b)(4). Of the data provided, the total protein results for two patient samples were discrepant and reported outside the laboratory. Patient sample 1 initial result was 8. 5 g/dl and the repeat result was 7. 0 g/dl. Patient sample 2 was from a female patient born on (b)(6). The initial result was 9. 1 g/dl and the repeat result was 7. 5 g/dl. The patients were not adversely affected. Upon evaluation of the analyzer, the field service representative determined there was a defective and disconnected level sense cable. He replaced the liquid level sense cable, worn ropes and a bent probe. He connected the valve cable above the transfer arm to the reagent module body. To verify the analyzer operation, he ran performance testing and the user ran and verified quality control.
Patient Sequence No: 1, Text Type: D, B5
[9010783]
Additional assays involved in this event are reported on the medwatch forms patient identifiers (b)(6).
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 1823260-2011-03324 |
| MDR Report Key | 2132768 |
| Report Source | 05,06 |
| Date Received | 2011-06-17 |
| Date of Report | 2011-06-17 |
| Date of Event | 2011-05-31 |
| Date Mfgr Received | 2011-06-01 |
| Date Added to Maude | 2011-06-17 |
| 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 RAE ANN FARROW |
| Manufacturer Street | 9115 HAGUE ROAD NA |
| Manufacturer City | INDIANAPOLIS IN 46250 |
| Manufacturer Country | US |
| Manufacturer Postal | 46250 |
| Manufacturer Phone | 3175213194 |
| 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 | 2011-06-17 |
| 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 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 | 2011-06-17 |