BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    0.8% SELECTOGEN FOR GEL

    MDR report key: 3994211 · Received August 8, 2014

    Report

    Report Number
    2250051-2014-00086
    Event Type
    Malfunction
    Date Received
    August 8, 2014
    Date of Event
    July 10, 2014
    Report Date
    August 8, 2014
    Manufacturer
    ORTHO CLINICAL DIAGNOSTICS
    Product Code
    KSZ
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NJ, US
    Reporter Occupation
    MEDICAL TECHNOLOGIST

    Narratives

    Additional Manufacturer Narrative · 1

    OCD PERFORMED RETAIN TESTING, BATCH REVIEW AND COMPLAINT REVIEW BY LOT. COMPLAINT REVIEW IDENTIFIED A TREND. SAMPLES RETURNED TO OCD FOR FURTHER INVESTIGATION AND CONFIRMED WHAT CUSTOMER REPORTED. ALTHOUGH RETAIN TESTING PASSED ALL RELEASE CRITERIA, DONOR WAS PERMANENTLY DEFERRED FROM FURTHER USE. (B)(4).

    Description of Event or Problem · 1

    CUSTOMER REPORTED FALSE NEGATIVE REACTIONS WITH 0.8% SELECTOGEN LOT VS748 CELL 2 WITH A SAMPLE THAT HAD A PREVIOUS HISTORY OF ANTI-E. CUSTOMER STATED THE SAMPLES WAS TESTED ON (B)(6) 2014 WITH SELECTOGEN LOT VS748 AND ANTIBODY SCREEN WAS REPORTED NEGATIVE BY PROVUE. BECAUSE OF PREVIOUS HISTORY OF ANTIBODY, PANEL ID USING 0.8% RESOLVE PANEL A WAS PERFORMED AND ANTI-E WAS CONFIRMED. CUSTOMER STATED DAILY QC WAS PERFORMED AND WAS ACCEPTABLE. REPEAT TESTING USING SAME LOT OF SCREENING CELLS AND GEL CARDS AND THE SAME 15 MINS INCUBATION TIME IN MANUAL GEL METHOD WAS PERFORMED AND NO REACTION NOTED WITH VS748.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    472726 0.8% SELECTOGEN FOR GEL REAGENT RED BLOOD CELLS KSZ ORTHO CLINICAL DIAGNOSTICS VS748

    Patients

    Seq Age Sex Outcome Treatment
    1