MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 1994-03-23 for CALCIUM REAGENT manufactured by Abbott Laboratories.
[8049]
Calcium reagent is unstable. Pt results run low and do not repeat precisely. Results are currently being compared to reference lab and do not correlate.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | MW1001186 |
| MDR Report Key | 12203 |
| Date Received | 1994-03-23 |
| Date of Report | 1994-03-08 |
| Date Added to Maude | 1994-03-24 |
| 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 |
| Reporter Occupation | RISK MANAGER |
| Health Professional | 3 |
| Initial Report to FDA | 0 |
| Report to FDA | 0 |
| Event Location | 3 |
| Single Use | 0 |
| Previous Use Code | 0 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | CALCIUM REAGENT |
| Generic Name | CALCIUM REAGENT |
| Product Code | JFP |
| Date Received | 1994-03-23 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Implant Flag | N |
| Date Removed | B |
| Device Sequence No | 1 |
| Device Event Key | 12203 |
| Manufacturer | ABBOTT LABORATORIES |
| Manufacturer Address | ABBOTT PARK IL 60064 US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1994-03-23 |