MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 1995-12-07 for IMX RUBELLA IGG TEST KIT manufactured by Abbott Diagnostics Div. Abbott Laboratories.
[21964230]
Invalid calibration runs. Valid calibration run shows shift to the high end of the curve. Pt results shifted to high end. Replacement shows not improvement.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | MW1007886 |
| MDR Report Key | 28572 |
| Date Received | 1995-12-07 |
| Date Added to Maude | 1995-12-11 |
| 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 | MEDICAL TECHNOLOGIST |
| 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 | IMX RUBELLA IGG TEST KIT |
| Generic Name | REAGENT |
| Product Code | KTO |
| Date Received | 1995-12-07 |
| Lot Number | 05476M200 |
| Device Expiration Date | 1995-12-26 |
| Operator | PHYSICIAN |
| Device Availability | * |
| Implant Flag | N |
| Date Removed | B |
| Device Sequence No | 1 |
| Device Event Key | 29527 |
| Manufacturer | ABBOTT DIAGNOSTICS DIV. ABBOTT LABORATORIES |
| Manufacturer Address | ABBOTT PARK IL 60064 US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1995-12-07 |