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 2018-09-19 for CRPL3 C-REACTIVE PROTEIN GEN.3 05172373190 manufactured by Roche Diagnostics.
[120833337]
The event occurred in: (b)(6).
Patient Sequence No: 1, Text Type: N, H10
[120833338]
The customer complained of questionable crpl3 c-reactive protein gen. 3 results from their cobas 8000 c (701) module where 26 amended reports had to be issued. From the data provided, a reportable malfunction occurred for 24 patients. The customer stated that on the day of the event, the qc results at 4:00, 7:00, and 10:30 were acceptable. At 13:30 the qc results were out of range low. The customer tried to calibrate the pack of reagent that was on the analyzer twice, but calibration failed both times. A new pack of reagent was loaded and the qc results were again acceptable. The customer repeated all patient samples that were tested between 10:30 and 13:30 and the discrepant patient results were found. There was no allegation of an adverse event. The cobas c701 serial number was (b)(4). On (b)(6) 2018 the customer reported another similar incident where the crpl3 qc results were low and acceptable results could not be obtained until a fresh pack of reagent was used. No patient samples were affected. This issue is only occurring on one instrument. The investigation is currently ongoing.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1823260-2018-03205 |
| MDR Report Key | 7890370 |
| Report Source | FOREIGN,HEALTH PROFESSIONAL,U |
| Date Received | 2018-09-19 |
| Date of Report | 2019-02-11 |
| Date of Event | 2018-09-02 |
| Date Mfgr Received | 2018-09-03 |
| Date Added to Maude | 2018-09-19 |
| 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 | 2018-09-19 |
| Model Number | NA |
| Catalog Number | 05172373190 |
| Lot Number | 351778 |
| 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 | 2018-09-19 |