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 |