BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ABS2000

    MDR report key: 1062614 · Received June 23, 2008

    Report

    Report Number
    1034569-2008-00203
    Event Type
    Malfunction
    Date Received
    June 23, 2008
    Date of Event
    May 28, 2008
    Report Date
    June 20, 2008
    Manufacturer
    IMMUCOR, INC.
    Product Code
    KSZ
    PMA / PMN Number
    BK960019
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    MEDICAL TECHNOLOGIST

    Narratives

    Additional Manufacturer Narrative · 1

    THE RETURNED PATIENT SAMPLE WAS TESTED IN HEMAGGLUTINATION USING SELECTED K+K+, K+K- AND K-K+ FROM PANOCELL-16, LOT 14611 USING IMMUADD AS THE POTENTIATOR. A ROOM TEMPERATURE INCUBATION WAS INCLUDED. THE SAMPLE WAS POSITIVE AT THE IGG PHASE ONLY.REACTIVITY OF THE K ANTIGEN WAS CONFIRMED ON RETENTION CAPTURE-R READY SCREEN (CRRS) (4), LOT G159 AND G160. THIS LOT OF CAPTURE WAS USED BY THE CUSTOMER. THE PATIENT SAMPLE WAS TESTED IN MANUAL SOLID PHASE WITH RETENTION CRRS(4), LOT G159 AND G160. THE SAMPLE EXHIBITED WEAK REACTIVITY (SCORE OF 4 ON K+K+ CELLS ON G159 AND SCORE OF 6 WITH G160 ON SCALE OF 0-8). THE SAMPLE WAS ALSO TESTED ON AN IN-HOUSE ABS2000 USING RETENTION CRRS(4), LOT G160; IT EXHIBITED POSITIVE REACTIVITY WITH K+K+ REAGENT RED CELLS. THE PATIENT'S SAMPLE WAS TESTED ON THE IN-HOUSE ABS2000 USING RETENTION CRRS(4), LOT G159; IT EXHIBITED NO REACTIVITY REACTIVITY WITH K+K+ REAGENT RED CELLS. POSITIVE REACTIVITY WITH K+K+ REAGENT RED CELLS WAS OBSERVED WITH THE PATIENT'S SAMPLE WHEN TESTED ON AN IN-HOUSE ECHO USING RETENTION CRRS(3).

    Description of Event or Problem · 1

    CUSTOMER REPORTED AN UNEXPECTED NEGATIVE REACTION ON THE ABS2000. A PATIENT SAMPLE WITH A KNOWN ANTI-KELL TESTED NEGATIVE ON THE ABS2000 AND 1+ POSITIVE IN GEL. THE ANTI-KELL WAS IDENTIFIED IN GEL AND PEG. A NEW PATIENT SAMPLE WAS OBTAINED APPROXIMATELY 5 DAYS LATER, AND GEL TESTING WAS PERFORMED ON BOTH SAMPLES. 2+ REACTIVITY WAS OBSERVED WITH BOTH SAMPLES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ABS2000 AUTOMATED BLOOD BANK ANALYZER KSZ IMMUCOR, INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 54 YR