BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CAPTURE-R READY ID TEST WELLS

    MDR report key: 1036003 · Received May 2, 2008

    Report

    Report Number
    1034569-2008-00121
    Event Type
    Malfunction
    Date Received
    May 2, 2008
    Date of Event
    April 3, 2008
    Report Date
    May 13, 2008
    Manufacturer
    IMMUCOR, INC.
    Product Code
    KSZ
    PMA / PMN Number
    102707 STN
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AZ, US
    Reporter Occupation
    MEDICAL TECHNOLOGIST

    Narratives

    Additional Manufacturer Narrative · 1

    "Reactivity of the K antigen was confirmed on retention Capture-R Ready-Screen (Pooled), lot N135, and Capture-R Ready-ID (CRRID), lot ID096.Manual solidphase testing was performed with the customer's 2 returned donor samples using retention CRRS (Pooled), lot N135, and selected D+ and K+k+ cells from CRRID, lot ID096. Both returned samples were nonreactive in all testing.Hemagglutination tube testing was performed at IS, 20'RT, 15' 37C, and IAT with customer's donors' samples using retention Panoscreen I, II, and III, lot 52421. ImmuAdd was used as potentiator. The sample reported to contain anti-D was nonreactive in all testing. The sample reported to contain anti-K exhibited 1+ reactivity at IAT with Cell III [K+k+;Yt(b+)]. The sample reported to contain anti-D was QNS for additional testing.Manual solidphase testing was performed with the sample reported to contain anti-K using retention Yt(b+) cells from CRRID, lot ID096.. The sample was nonreactive in all testing. Hemagglutination tube testing was then performed with this sample using K+k-, K-, and K+k+ cells. ImmuAdd was used as potentiator. Sample exhibited 1+s reactivity with K+k- cell, weak reactivity with K+k+ cell, and was nonreactive with K- cell.Reactivity of the K antigen was confirmed on retention Capture-R Ready-ID, lot ID097.Manual solidphase testing was performed with the sample reported to contain anti-K using K+k-, K+k+, and K- cells from retention CRRID, lot ID097. The sample exhibited weak reactivity (scores of 4 to 4/5 on a scale of 0 to 10) with K+k+ cells and moderate reactivity (score of 6) with K+k- cell. The sample was nonreactive with K- cell."

    Additional Manufacturer Narrative · 1

    THE INVESTIGATION IS ONGOING.

    Description of Event or Problem · 1

    CUSTOMER REPORTED, UNEXPECTED NEGATIVE REACTIONS ON THE GALILEO WITH THE ABID ASSAY. ANTI-D AND ANTI K ANITBODIES WERE NOT DETECTED IN 2 DONOIR SAMPLES, RESPECTIVELY.

    Description of Event or Problem · 1

    CUSTOMER REPORTED, UNEXPECTED NEGATIVE REACTIONS ON THE GALILEO WITH THE ABID ASSAY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CAPTURE-R READY ID TEST WELLS REAGENT RED BLOOD CELLS KSZ IMMUCOR, INC. ID 096

    Patients

    Seq Age Sex Outcome Treatment
    1