BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CAPTURE-R READY-SCREEN TEST WELLS

    MDR report key: 866770 · Received June 15, 2007

    Report

    Report Number
    1034569-2007-00145
    Event Type
    Malfunction
    Date Received
    June 15, 2007
    Date of Event
    May 18, 2007
    Report Date
    June 15, 2007
    Manufacturer
    IMMUCOR
    Product Code
    KSZ
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THE PRESENCE OF THE K ANTIGEN WAS CONFIRMED ON CRRS (I AND II), LOT X187 AND CRRID, LOT ID082. CUSTOMER RETURNED THE SAMPLE FOR INVESTIGATION TESTING. THE PT'S SAMPLES WERE TESTED ON RETENTION CRRS (I AND II), LOT X187 AND CRRID, LOT ID082. THE PT'S SAMPLES EXHIBITED NO REACTIVITY WITH ALL CELLS TESTED. THE PT'S SAMPLES WERE TESTED BY MANUAL TUBE METHOD USING PANOSCREEN I, II AND III, LOT 11848 WITH N-HANCE, LOT NH56-3 AS THE POTENTIATOR. A ROOM TEMPERATURE INCUBATION WAS INCLUDED. THE PT'S SAMPLES EXHIBITED REACTIVITY AT 20'RT WITH CELL #I (K+K+). NO REACTIVITY WAS OBSERVED AT THE 37C AND IAT PHASES OF TESTING. TESTING WAS REPEATED WITH READING ONLY AT IAT FOLLOWING THE 37C INCUBATION; NO REACTIVITY WAS OBSERVED. THIS SUGGEST THE PT'S ANTI-K IS IGM IN NATURE. CAPTURE-R IS DESIGNED TO DETECT UNEXPECTED IGG ANTIBODIES TO RED CELLS.

    Description of Event or Problem · 1

    CUSTOMER REPORTEDLY UNEXPECTED NEGATIVE REACTIONS WITH CAPTURE-R READY-SCREEN (II) AND CAPTURE-R READY-ID WHEN TESTING PT SAMPLE CONTAINING AN ANTI-K. MANUAL TESTING BY A TUBE METHOD RESULTED IN MICROSCOPIC REACTIVITY AT THE AHG PHASE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CAPTURE-R READY-SCREEN TEST WELLS REAGENT RED BLOOD CELLS KSZ IMMUCOR X187

    Patients

    Seq Age Sex Outcome Treatment
    1 YR