MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2010-11-09 for INSTRUMENT: COBAS C311 manufactured by Roche Diagnostics Corp/roche Centralized And Molecular Diagnostics.
[1668656]
Apparently the calcium reagent was the issue as no other lab results were impacted, (a specific lot#) was recalled and we were not notified. The lab machine reported 3 high calcium levels on pt causing us to notify company.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | MW5018171 |
| MDR Report Key | 1899774 |
| Date Received | 2010-11-09 |
| Date of Report | 2010-11-09 |
| Date of Event | 2010-09-27 |
| Date Added to Maude | 2010-11-19 |
| Event Key | 0 |
| Report Source Code | Voluntary report |
| Manufacturer Link | N |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 3 |
| Product Problem Flag | 3 |
| Reprocessed and Reused Flag | 0 |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 0 |
| Event Location | 0 |
| Single Use | 0 |
| Previous Use Code | 0 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | INSTRUMENT: COBAS C311 |
| Generic Name | NONE |
| Product Code | CIT |
| Date Received | 2010-11-09 |
| Operator | HEALTH PROFESSIONAL |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | ROCHE DIAGNOSTICS CORP/ROCHE CENTRALIZED AND MOLECULAR DIAGNOSTICS |
| Manufacturer Address | 9115 HAGUE RD PO BOX 50457 INDIANAPOLIS IN 46250045 US 46250 0457 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 2010-11-09 |