MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a foreign,health professional,u report with the FDA on 2016-10-07 for CRPL3 C-REACTIVE PROTEIN GEN.3 05172373190 manufactured by Roche Diagnostics.
[56961663]
(b)(4). This event occurred in (b)(4).
Patient Sequence No: 1, Text Type: N, H10
[56961664]
The customer received questionable crpl3 c-reactive protein gen. 3 results from two roche analyzers. Information was provided that one was cobas 8000 serial number (b)(4). The customer had recently started using this reagent lot and the qc was drifting to +3sd throughout the day. The customer recalibrates the assay and the qc comes back within the acceptable limits. The customer also saw an affect to patient sample results. Of the data provided for (b)(6) patient samples, one was discrepant. The first result was 122. 84 mg/l and a repeat result was 89. 46 mg/l after the reagent was recalibrated and qc performed. Information regarding if any erroneous result was reported outside the lab was requested but it was unknown. No patient was adversely affected. The customer previously had the exact same issue with crp around a year or so ago. In that instance the issue was resolved by using a new lot of reagent. Based on the data provided, the calibrations appeared acceptable and no differences were obvious. No drift was noted in the qc data except for qc with a concentration of 118 mg/l.
Patient Sequence No: 1, Text Type: D, B5
[60490683]
The laboratory support coordinator checked the handling of the calibrators and reagents and installed a new lot of calibrator material on the analyzers. Since this visit, there have been no further issues so it appeared that either the mixing of the reagent or the new calibrator lot resolved the issue. A specific root cause could not be determined. Additional information for further investigation was requested but was not provided.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 1823260-2016-01535 |
| MDR Report Key | 6010610 |
| Report Source | FOREIGN,HEALTH PROFESSIONAL,U |
| Date Received | 2016-10-07 |
| Date of Report | 2016-11-14 |
| Date of Event | 2016-09-16 |
| Date Mfgr Received | 2016-09-16 |
| Date Added to Maude | 2016-10-07 |
| 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 | 3 |
| Event Location | 3 |
| Manufacturer Contact | NA MICHAEL LESLIE |
| Manufacturer Street | 9115 HAGUE ROAD NA |
| Manufacturer City | INDIANAPOLIS IN 46250 |
| Manufacturer Country | US |
| Manufacturer Postal | 46250 |
| Manufacturer Phone | 3175214343 |
| Manufacturer G1 | ROCHE DIAGNOSTICS GMBH |
| Manufacturer Street | SANDHOFERSTRASSE 116 NA |
| Manufacturer City | MANNHEIM (BADEN-WURTTEMBERG) 68305 |
| Manufacturer Country | GM |
| Manufacturer Postal Code | 68305 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Removal Correction Number | NA |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | CRPL3 C-REACTIVE PROTEIN GEN.3 |
| Generic Name | C-REACTIVE PROTEIN IMMUNOLOGICAL TEST SYSTEM |
| Product Code | DCN |
| Date Received | 2016-10-07 |
| Model Number | NA |
| Catalog Number | 05172373190 |
| Lot Number | 157142 |
| ID Number | NA |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| 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 462500457 US 462500457 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2016-10-07 |