MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2019-04-25 for CRPL3 C-REACTIVE PROTEIN GEN.3 CRP G3 manufactured by Roche Diagnostics.
[143416410]
The investigations for the 1 event did not identify a product problem. The cause of the event could not be determined. The samples were submitted for investigation where the customer's high crpl3 results were not confirmed. The customer's repeat results were confirmed during the investigation. The follow up/corrective actions for the 1 event were as follows: the field service engineer adjusted the gear pump pressure, checked the rinsing of the cuvettes which were ok and replaced reagent and sample probes. Qc was acceptable. Sample material was requested for investigation. No devices were returned. This device is not labeled for single use and is not reprocessed or reused.
Patient Sequence No: 1, Text Type: N, H10
[143416411]
This report summarizes
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1823260-2019-90091 |
| MDR Report Key | 8549746 |
| Date Received | 2019-04-25 |
| Date Added to Maude | 2019-04-25 |
| 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 | 0 |
| Initial Report to FDA | 0 |
| Report to FDA | 3 |
| Event Location | 3 |
| Manufacturer Contact | 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 | SANDHOFFERSTRASSE 116 NA |
| Manufacturer City | MANNHEIM (BADEN-WURTTEMBERG), NA 68305 |
| Manufacturer Country | GM |
| Manufacturer Postal Code | 68305 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 0 |
| Brand Name | CRPL3 C-REACTIVE PROTEIN GEN.3 |
| Generic Name | C-REACTIVE PROTEIN IMMUNOLOGICAL TEST SYSTEM |
| Product Code | DCN |
| Date Received | 2019-04-25 |
| Model Number | CRP G3 |
| Lot Number | 383790 |
| Device Availability | * |
| Device Eval'ed by Mfgr | * |
| 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 | 2019-04-25 |