BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CAPTURE-R READY-SCREEN (4)

    MDR report key: 3124104 · Received May 22, 2013

    Report

    Report Number
    1034569-2013-00087
    Event Type
    Malfunction
    Date Received
    May 22, 2013
    Date of Event
    April 29, 2013
    Report Date
    May 22, 2013
    Manufacturer
    IMMUCOR, INC.
    Product Code
    KSZ
    PMA / PMN Number
    STN 102707
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GA, US
    Reporter Occupation
    MEDICAL TECHNOLOGIST

    Narratives

    Additional Manufacturer Narrative · 1

    A REVIEW OF THE RESULT FILES FOR THE UNEXPECTED NEGATIVE REACTIVITY SHOWED THAT NEGATIVE REACTIVITY APPEARED NEGATIVE AS REPORTED BY THE INSTRUMENT. THE IMMUCOR PRODUCT INVESTIGATION LAB CONFIRMED THE PRESENCE OF THE FYA ANTIGEN ON RETENTION PRODUCT. ANTIBODY SCREENING AND IDENTIFICATION ASSAYS WERE PERFORMED ON THE CUSTOMERS SUBMITTED SAMPLE. SAMPLE, (B)(4), CELL 1 RESULTED EQUIVOCAL (FUZZY BUTTON BUT LOOKS NEGATIVE), CELL 2 POSITIVE AND CELLS 3 AND 4 WERE NEGATIVE. SAMPLE WAS REPEATED USING THE SAME LOT OF REAGENTS, CELL 1 RESULTED EQUIVOCAL (FUZZY BUTTON BUT LOOKS NEGATIVE), CELLS 2 AND 3 WERE POSITIVE AND CELL 4 WERE NEGATIVE. PERFORMED AN ANTIBODY ID ON CUSTOMER'S SAMPLE, (B)(4), ON THE ECHO USING RETENTION CAPTUE-R READY-ID EXTEND I, LOT DP061 AND CAPTURE-R READY INDICATOR RED CELL, LOT 221970. CONTROLS PERFORMED AS EXPECTED, CELL 8 RESULTED EQUIVOCAL (FUZZY BUTTON BUT, LOOKS NEGATIVE), AND ALL OTHER CELLS RESULTED NEGATIVE. SAMPLE WAS REPEATED USING THE SAME LOT OF REAGENTS. CONTROLS PERFORMED AS EXPECTED. SAMPLE, (B)(4), RESULTED NEGATIVE ON ALL CELLS. ISSUE APPEARS TO BE UNIQUE TO THIS SAMPLE.

    Description of Event or Problem · 1

    A CUSTOMER REPORTED OBTAINING UNEXPECTED NEGATIVE REACTIVITY WITH THE ANTIBODY SCREENING AND IDENTIFICATION ASSAYS ON THE GALILEO WITH A SAMPLE CONTAINING ANTI-FYA.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    225930 CAPTURE-R READY-SCREEN (4) REAGENT RED BLOOD CELLS KSZ IMMUCOR, INC. K331

    Patients

    Seq Age Sex Outcome Treatment
    1 82 YR