IMX RUBELLA IGG TEST KIT

MAUDE Adverse Event Report

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.

Event Text Entries

[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


MAUDE Entry Details

Report NumberMW1007886
MDR Report Key28572
Date Received1995-12-07
Date Added to Maude1995-12-11
Event Key0
Report Source CodeVoluntary report
Manufacturer LinkN
Number of Patients in Event0
Adverse Event Flag3
Product Problem Flag3
Reprocessed and Reused Flag0
Reporter OccupationMEDICAL TECHNOLOGIST
Health Professional3
Initial Report to FDA0
Report to FDA0
Event Location3
Single Use0
Previous Use Code0
Event Type3
Type of Report3

Device Details

Brand NameIMX RUBELLA IGG TEST KIT
Generic NameREAGENT
Product CodeKTO
Date Received1995-12-07
Lot Number05476M200
Device Expiration Date1995-12-26
OperatorPHYSICIAN
Device Availability*
Implant FlagN
Date RemovedB
Device Sequence No1
Device Event Key29527
ManufacturerABBOTT DIAGNOSTICS DIV. ABBOTT LABORATORIES
Manufacturer AddressABBOTT PARK IL 60064 US


Patients

Patient NumberTreatmentOutcomeDate
10 1995-12-07

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