BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CAPTURE-R READY-ID

    MDR report key: 2732328 · Received September 7, 2012

    Report

    Report Number
    1034569-2012-00163
    Event Type
    Malfunction
    Date Received
    September 7, 2012
    Date of Event
    August 8, 2012
    Report Date
    September 7, 2012
    Manufacturer
    IMMUCOR, INC.
    Product Code
    KSZ
    PMA / PMN Number
    STN 102707
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    LA, US
    Reporter Occupation
    MEDICAL TECHNOLOGIST

    Narratives

    Additional Manufacturer Narrative · 1

    THE IMAGE RESULT FILES WERE NOT AVAILABLE FOR REVIEW. IMMUCORS PRODUCT INVESTIGATIONS LAB CONFIRMED THE PRESENCE OF THE E ANTIGEN ON RETENTION CAPTURE-R READY-SCREEN I AND II, LOT X364 AND CAPTURE-R READY-ID, LOTS ID163 AND ID162. MANUAL CAPTURE TESTING WAS ALSO PERFORMED ON THE CUSTOMERS SUBMITTED SAMPLE, USING RETENTIONS CAPTURE-R READY-SCREEN I AND II, (CRRS2), LOT X364 AND CAPTURE-R READY-ID, (CRRID), LOTS ID163 AND ID162. CONTROLS PERFORMED AS EXPECTED AND ALL REAGENT RED CELLS EXHIBITED NEGATIVE REACTION ON ALL E+ CELLS. AN ANTIBODY IDENTIFICATION PANEL WAS PERFORMED ON THE SUBMITTED SAMPLE ON THE GALILEO USING RETENTIONS CRRID, LOT ID163 AND CRRIRC, LOT 221853. CONTROLS PERFORMED AS EXPECTED. ALL E+ CELLS RESULTED NEGATIVE. THE UNEXPECTED REACTIVITY APPEARS TO BE SAMPLE-RELATED.

    Description of Event or Problem · 1

    A CUSTOMER REPORTED OBTAINING AN UNEXPECTED NEGATIVE REACTION WITH THE ANTIBODY SCREENING AND IDENTIFICATION ASSAYS ON THE GALILEO.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CAPTURE-R READY-ID REAGENT RED BLOOD CELLS KSZ IMMUCOR, INC. ID162

    Patients

    Seq Age Sex Outcome Treatment
    1 17