BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ECHO

    MDR report key: 1343267 · Received March 16, 2009

    Report

    Report Number
    1034569-2009-00087
    Event Type
    Malfunction
    Date Received
    March 16, 2009
    Date of Event
    February 17, 2009
    Report Date
    March 9, 2009
    Manufacturer
    IMMUCOR
    Product Code
    KSZ
    PMA / PMN Number
    BK070016
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NV, US
    Reporter Occupation
    MEDICAL TECHNOLOGIST

    Narratives

    Additional Manufacturer Narrative · 1

    REACTIVITY OF THE K ANTIGEN WAS CONFIRMED ON RETENTION CAPTURE-R READY SCREEN (CRRS) (3), LOT R037, CAPTURE-R READY ID (CRRID), LOT ID111, AND CAPTURE-R READY ID EXTEND II, LOT DN032 USED BY THE CUSTOMER AT THE TIME OF THE EVENT. ANITBODY SCREEN TESTING WAS PERFORMED WITH CUSTOMER'S RETURNED SAMPLE USING RETENTION CRRS (3), LOT R037 ON AN IN-HOUSE ECHO. THE SAMPLE WAS NONREACTIVE IN ALL ECHO TESTING. HEMAGGLUTINATION TUBE TESTING WAS PERFORMED WITH CUSTOMER'S SAMPLE USING RETENTION PANOSCREEN (I, II, AND III), LOT 52180. IMMUADD, WAS USED AS POTENTIATOR AND SAMPLE WAS TESTED AT ALL TEMPERATURES. THE SAMPLE EXHIBITED 1+S REACTIVITY AT IAT WITH CELL I (K+ DONOR) AND WAS NONREACTIVE WITH K-NEGATIVE CELLS II AND III. MANUAL TESTING WAS PERFORMED WITH THE CUSTOMER'S SAMPLE USING K+K+ CELLS FROM RETENTION CRRID EXTEND II, LOT DN032, AND CRIRC, LOT 221327. SAMPLE WAS NONREACTIVE IN ALL TESTING. MANUAL TESTING WAS PERFORMED WITH CUSTOMER'S SAMPLE USING K+K- CELL 14 FROM RETENTION CRRID, LOT ID111. THE SAMPLE WAS NONREACTIVE IN ALL TESTING. THE PATIENT'S SAMPLE AND ANTI-K, LOT S5332-2 DILUTED 1:100 ( TO CONFIRM K ANTIGEN REACTIVITY) WERE MANUALLY TESTED WITH RETENTION CAPTURE-R SELECT, LOT SC106, USING CELI I (K+K+) AND CELL II (K-K+) REAGENT RED CELLS FROM RETENTION PANOSCREEN I, II AND III, LOT 52180 AS MONOLAYERS. THE SAMPLE EXHIBITED POSITIVE REACTIVITY (SCORE OF 8 ON SCALE FROM 0-10) WITH K+K+ REAGENT RED CELLS. THE PRESENCE OF THE K ANTIGEN WAS CONFIRMED. A DHR REVIEW WAS CONDUCTED TO VERIFY REACTIVITY OF THE K ANTIGEN ON CRRS, LOT R037. THE DHR REVIEW CONFIRMED THE K ANTIGEN MET ACCEPTANCE CRITERIA FOR IDENTITY TESTING.

    Description of Event or Problem · 1

    CUSTOMER REPORTED AN UNEXPECTED NEGATIVE REACTION ON THE ECHO. ANTIBODY SCREEN WAS NEGATIVE, BUT THE PATIENT WAS TESTED IN GEL WITH A REACTION OF 3+ FOR ANTI-KELL AND IN TUBE/PEG WITH A 3+ REACTION FOR ANTI-KELL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ECHO AUTOMATED BLOOD BANK ANALYZER KSZ IMMUCOR

    Patients

    Seq Age Sex Outcome Treatment
    1