BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CAPTURE-R READY SCREEN (3)

    MDR report key: 2744162 · Received September 13, 2012

    Report

    Report Number
    1034569-2012-00158
    Event Type
    Malfunction
    Date Received
    September 13, 2012
    Date of Event
    August 2, 2012
    Report Date
    August 31, 2012
    Manufacturer
    IMMUCOR, INC.
    Product Code
    KSZ
    PMA / PMN Number
    STN 102707
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    MEDICAL TECHNOLOGIST

    Narratives

    Additional Manufacturer Narrative · 1

    THE CUSTOMER RETURNED THE PRODUCT AND SUBMITTED THE SAMPLE FOR INVESTIGATION. THE PRODUCT INVESTIGATIONS LAB CONFIRMED THE PRESENCE OF THE E ANTIGEN ON RETENTION AND RETURNED PRODUCT (LOT R233). AN ANTIBODY SCREENING ASSAY WAS PERFORMED ON THE SUBMITTED SAMPLE USING THE RETURNED PRODUCT. EQUIVOCAL (?) RESULTS WERE OBTAINED WITH CELL 2. REPEAT TESTING RESULTED IN A NEGATIVE INTERPRETATION BY THE ECHO. CELL 2 VISUALLY APPEARED POSITIVE. AN ANTIBODY SCREENING ASSAY WAS PERFORMED ON THE SAMPLE USING RETENTION PRODUCT (LOT R233) AND RETURNED INDICATOR CELLS, LOT 221851. CONTROLS PERFORMED AS EXPECTED. THE ECHO RESULTED IN NO INTERPRETATION DUE TO EQUIVOCAL (?) REACTIVITY WITH CELL 2 (VISUALLY POSITIVE). REPEAT TESTING RESULTED IN NEGATIVE INTERPRETATION BY THE ECHO, BUT CELL 2 APPEARED VISUALLY POSITIVE. THE SAMPLE WAS AGAIN TESTED ON THE ECHO USING RETENTION CRRS3, LOT R233, AND RETENTION CRRIRC, LOT 221851. CONTROLS PERFORMED AS EXPECTED. THE ECHO RESULTED AS NEGATIVE ON THE ECHO IN BOTH RUNS. CELL 2 APPEARED VISUALLY POSITIVE. MANUAL CAPTURE TESTING WAS PERFORMED USING THE RETURNED AND RETENTION CRRS3 AND INDICATOR CELLS. INCUBATION TIME WAS INCREASED TO 60 MINUTES. CONTROLS PERFORMED AS EXPECTED AND THE SAMPLE EXHIBITED POSITIVE REACTIVITY WITH CELL 2. THE INVESTIGATION DID NOT IDENTIFY A PRODUCT DEFICIENCY. THE REACTIVITY OBSERVED APPEARS TO BE UNIQUE TO THE NATURE OF THE CUSTOMERS SAMPLE. THE SAMPLES ANTI-E MAY BE AT OR BELOW THE THRESHOLD OF DETECTION BY CAPTURE METHODOLOGY.

    Description of Event or Problem · 1

    A CUSTOMER REPORTED THAT UNEXPECTED NEGATIVE AND EQUIVOCAL (?) REACTIONS WERE OBTAINED WITH CAPTURE-R READY-SCREEN (3), LOT R233.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CAPTURE-R READY SCREEN (3) REAGENT RED BLOOD CELLS KSZ IMMUCOR, INC. R233

    Patients

    Seq Age Sex Outcome Treatment
    1 66 YR