BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CAPTURE-R READY-SCREEN (3)

    MDR report key: 2792667 · Received October 16, 2012

    Report

    Report Number
    1034569-2012-00195
    Event Type
    Malfunction
    Date Received
    October 16, 2012
    Date of Event
    September 18, 2012
    Report Date
    October 16, 2012
    Manufacturer
    IMMUCOR, INC.
    Product Code
    KSZ
    PMA / PMN Number
    STN 102707
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AL, US
    Reporter Occupation
    MEDICAL TECHNOLOGIST

    Narratives

    Additional Manufacturer Narrative · 1

    REVIEW OF THE IMAGE RESULT FILES SHOWED THAT NEGATIVE RESULTS WERE OBTAINED WITH ALL CELLS OF THE SCREENING ASSAYS. RESULTS VISUALLY APPEARED NEGATIVE AS REPORTED BY THE ECHO INSTRUMENTS. CONTROLS REACTED AS EXPECTED. A REVIEW OF THE COLOR CHECK IMAGES SHOWED THAT PLASMA HAD BEEN ADDED TO ALL TEST WELLS FOR BATCHES REVIEWED. THE CUSTOMER WAS ADVISED THAT WE WERE UNABLE TO RULE OUT IF THE POUCH OF CRRS3 STRIPS, LOT R235, THAT WERE USED ON BOTH INSTRUMENTS WERE COMPROMISED. THE PRODUCT IS PERFORMING AS EXPECTED.

    Description of Event or Problem · 1

    A CUSTOMER REPORTED OBTAINING UNEXPECTED NEGATIVE RESULTS WITH CAPTURE-R READY-SCREEN (3) TEST WELLS (CRRS3), LOT R235, ON TWO GALILEO ECHO INSTRUMENTS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CAPTURE-R READY-SCREEN (3) REAGENT RED BLOOD CELL KSZ IMMUCOR, INC. R235

    Patients

    Seq Age Sex Outcome Treatment
    1