MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05,06 report with the FDA on 2012-05-02 for C-REACTIVE PROTEIN GEN.3 04956842190 manufactured by Roche Diagnostics.
[17134797]
The user received questionable c-reactive protein generation 3 (crp) results from the cobas c501 analyzer serial number (b)(4) and provided data for 13 patient samples. Of the provided data, only the results for one patient sample were discrepant and reported outside the laboratory. The initial result was 1. 52 mg/dl with a data flag and was reported. The repeat result was 8. 84 mg/dl with a data flag. A corrective report was sent and the patient was not adversely affected. The field application specialist determined there was a faulty reagent pack. He removed the current reagent pack and switched to the stand-by pack. He compared the patient sample results to a second analyzer line that was not giving the data flags. After switching to the stand-by pack, the patient results no longer had the data flags and matched the second analyzer line.
Patient Sequence No: 1, Text Type: D, B5
[17185267]
.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 1823260-2012-02343 |
| MDR Report Key | 2556895 |
| Report Source | 05,06 |
| Date Received | 2012-05-02 |
| Date of Report | 2012-05-02 |
| Date of Event | 2012-04-18 |
| Date Mfgr Received | 2012-04-18 |
| Date Added to Maude | 2012-05-02 |
| 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 | C-REACTIVE PROTEIN GEN.3 |
| Generic Name | SYSTEM, TEST, C-REACTIVE PROTEIN |
| Product Code | DCN |
| Date Received | 2012-05-02 |
| Model Number | NA |
| Catalog Number | 04956842190 |
| Lot Number | 65303001 |
| ID Number | NA |
| Device Expiration Date | 2013-02-28 |
| 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 | 2012-05-02 |