BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CAPTURE-R READY ID EXTEND I

    MDR report key: 1081907 · Received July 29, 2008

    Report

    Report Number
    1034569-2008-00269
    Event Type
    Malfunction
    Date Received
    July 29, 2008
    Date of Event
    July 1, 2008
    Report Date
    July 24, 2008
    Manufacturer
    IMMUCOR, INC.
    Product Code
    KSZ
    PMA / PMN Number
    102707 STN
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TN, US
    Reporter Occupation
    MEDICAL TECHNOLOGIST

    Narratives

    Additional Manufacturer Narrative · 1

    THE RETURNED PATIENT'S SAMPLES WERE TESTED ON AN IN-HOUSE ECHO USING RETENTION CRRS(3), LOT R023. ONE OF THE SAMPLES EXHIBITED POSITIVE REACTIVITY WITH ALL THREE REAGENT RED CELLS. THIS SAMPLE WAS TESTED WITH RETENTION CRRID, LOT ID101. CELL 3 WAS INTERPRETED AS POSITIVE BY THE ECHO. THE SAMPLE WAS AGAIN REPEATED ON THE ECHO USING RETENTION CRRS(3), LOT R023. ALL THREE CELLS WERE NEGATIVE ON REPEAT RUN. THE SAMPLES WERE TESTED BY MANUAL TUBE METHOD WITH PANOSCREEN REAGENT RED BLOOD CELLS, USING IMMUADD AS THE POTENTIATOR. THE SAMPLES SHOWED NO EACTIVITY AT ANY PHASE OF TESTING. THE SAMPLE WAS RETESTED USING RETENTION CRRS(3), LOT R023. THE SAMPLE EXHIBITED POSITIVE REACTIVITY WITH CELL II. REACTIVITY OF THE E ANTIGEN WAS CONFIRMED ON RETENTION CRRID EXTEND I, LOT DP028. THE SAMPLE WAS TESTED WITH TWO E- AND TWO E+ REAGENT RED CELLS OF RETENTION CRRID EXTEND I, LOT DP028. THE SAMPLE EXHIBITED NO REACTIVITY WITH E+ REAGENT RED CELLS OF RETENTION CRRID EXTEND I, LOT DP028. VERY LIMITED SAMPLE WAS AVAILABLE FOR TESTING.

    Description of Event or Problem · 1

    CUSTOMER REPORTED UNEXPECTED NEGATIVE REACTIONS WITH CELLS #8, 10, 12(HOMOZYGOUS E CELLS) AND CELL #7(HETEROZYGOUS E CELL) ON CAPTURE-R READY ID (CRRID) EXTEND I, LOT #DP028, EXP. 8/05/08 WHEN TESTING A PATIENT SAMPLE CONTAINING ANTI-E. NO ADVERSE REACTIONS OCCURRED AS A RESULT OF THE UNEXPECTED NEGATIVE REACTIONS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CAPTURE-R READY ID EXTEND I REAGENT RED BLOOD CELLS KSZ IMMUCOR, INC. DP028

    Patients

    Seq Age Sex Outcome Treatment
    1 75 YR