BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CAPTURE-R READY INDICATOR RED CELLS

    MDR report key: 1545305 · Received November 25, 2009

    Report

    Report Number
    1034569-2009-00423
    Event Type
    Malfunction
    Date Received
    November 25, 2009
    Date of Event
    October 28, 2009
    Report Date
    November 25, 2009
    Manufacturer
    IMMUCOR
    Product Code
    KSZ
    PMA / PMN Number
    BK020053
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    MEDICAL TECHNOLOGIST

    Narratives

    Additional Manufacturer Narrative · 1

    REVIEW OF INSTRUMENT RESULTS: CRRID STRIP LOT ID119, CAPTURE-R READY INDICATOR RED CELLS (CRIRC) LOT 221422. 0 STRIP 1 WELL 1=1 (HOMOZYGOUS FOR C ) ( REVIEW OF THE IMAGE APPEARS NEGATIVE); 0 STRIP 1 WELL 2=1 (HOMOZYGOUS FOR C ) ( REVIEW OF THE IMAGE APPEARS NEGATIVE); 0 STRIP 1 WELL 5=1 (HETEROZYGOUS FOR C) ( REVIEW OF THE IMAGE APPEARS NEGATIVE); 0 STRIP 2 WELL 14=1 (HOMOZYGOUS FOR C ) ( REVIEW OF THE IMAGE APPEARS NEGATIVE); ALL OTHER WELLS WERE ANTIGEN NEGATIVE AND REACTED NEGATIVE AS EXPECTED . CRRS3 STRIP LOT R058, CAPTURE-R READY INDICATOR CELLS; 0 STRIP 2 WELL 1=2 (HOMOZYGOUS FOR C ) ( REVIEW OF THE IMAGE APPEARS NEGATIVE); ALL OTHER WELLS WERE ANTIGEN NEGATIVE AND REACTED NEGATIVE AS EXPECTED . CRRID STRIP LOT ID120, CAPTURE-R READY INDICATOR CELLS LOT 221422; 0 STRIP 1 WELL 1=1 HOMOZYGOUS FOR C ) ( REVIEW OF THE IMAGE APPEARS NEGATIVE); 0 STRIP 1 WELL 2=1 HOMOZYGOUS FOR C ) ( REVIEW OF THE IMAGE APPEARS NEGATIVE); 0 STRIP 1 WELL 5=2(HETEROZYGOUS FOR C) ( REVIEW OF THE IMAGE APPEARS NEGATIVE); 0 STRIP 2 WELL 14=2 HOMOZYGOUS FOR C ) ( REVIEW OF THE IMAGE APPEARS NEGATIVE); ALL OTHER WELLS WERE ANTIGEN NEGATIVE AND REACTED NEGATIVE AS EXPECTED . CONFIRMED THE REACTIVITY OF THE C ANTIGEN ON RETENTION CRRID LOT ID120, USING CRIRC LOT 221422. CRRID ASSAY PERFORMED WITH CUSTOMER'S PATIENT SAMPLE (REPORTED TO CONTAIN ANTI-C) USING RETENTION CRRID, LOT ID120, AND CRIRC, LOT 221429, ON IN-HOUSE ECHO. SAMPLE EXHIBITED 2+ TO 3+ POSITIVE REACTIVITY WITH ALL C+ CELLS AND WAS NONREACTIVE WITH ALL C- CELLS. ALL RETENTION PRODUCTS PERFORMED AS EXPECTED.

    Description of Event or Problem · 1

    CUSTOMER REPORTED A PATIENT SAMPLE WITH KNOWN HISTORY OF ANTI-C WAS TESTED ON THE ECHO 3 TIMES, FIRST WITH CAPTURE-R READY ID (CRRID) LOT ID 119, SECOND WITH CAPTURE-R READY SCREEN 3 (CRRS 3) AND A THIRD TIME WITH CRRID LOT ID120. THE RESULTS WERE NEGATIVE WITH ALL THREE ASSAYS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CAPTURE-R READY INDICATOR RED CELLS ANTI-IGG COATED RED CELLS FOR USE IN SOLID PHASE ASSAY KSZ IMMUCOR 221422

    Patients

    Seq Age Sex Outcome Treatment
    1 35 YR