BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ORTHO REAGENT RED BLOOD CELLS 0.8% SELECTOGEN

    MDR report key: 3973864 · Received August 1, 2014

    Report

    Report Number
    2250051-2014-00084
    Event Type
    Malfunction
    Date Received
    August 1, 2014
    Date of Event
    July 10, 2014
    Report Date
    August 1, 2014
    Manufacturer
    ORTHO CLINICAL DIAGNOSTICS
    Product Code
    KSZ
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN, US
    Reporter Occupation
    MEDICAL TECHNOLOGIST

    Narratives

    Additional Manufacturer Narrative · 1

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

    Description of Event or Problem · 1

    CUSTOMER REPORTING FALSE NEGATIVE REACTION WITH THE 0.8% SELECTOGEN LOT VS748 WITH 1 SAMPLE THAT HAD PREVIOUS HISTORY OF ANTI-E ISSUE STARTED ON: (B)(6) 2014 FREQUENCY: 1X CELL #2 METHODOLOGY USED: PROVUE/GEL METHOD REACTION GRADE OBTAINED: NEGATIVE CUSTOMER WAS EXPECTING: POSITIVE REACTION TEST REPEATED: YES CUSTOMER STATED SAMPLE WAS TESTED ON (B)(6) 2014 WITH SELECTOGEN LOT VS748 AND ANTIBODY SCREEN WAS NEGATIVE BY PROVUE. BECAUSE OF PREVIOUS HISTORY OF ANTIBODY, TECH DID PANEL ID USING 0.8% RESOLVE PANEL A AND ANTI-E WAS CONFIRMED REPEAT ANTIBODY SCREEN TESTING USING SAME LOT OF SCREENING CELLS AND GEL CARDS AND 15 MINS INCUBATION, AND STILL NO REACTION NOTED USING MANUAL GEL METHOD. OCD SENT REPLACEMENT LOT OF SCREENING CELLS TO ASSIST IN TROUBLESHOOTING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    450362 ORTHO REAGENT RED BLOOD CELLS 0.8% SELECTOGEN REAGENT RED BLOOD CELLS KSZ ORTHO CLINICAL DIAGNOSTICS VS748

    Patients

    Seq Age Sex Outcome Treatment
    1