BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CAPTURE-R SELECT

    MDR report key: 4162162 · Received October 10, 2014

    Report

    Report Number
    1034569-2014-00178
    Event Type
    Malfunction
    Date Received
    October 10, 2014
    Date of Event
    September 11, 2014
    Report Date
    October 9, 2014
    Manufacturer
    IMMUCOR, INC.
    Product Code
    KSZ
    PMA / PMN Number
    BK040024
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    MEDICAL TECHNOLOGIST

    Narratives

    Additional Manufacturer Narrative · 1

    IMMUCOR TECHNICAL SUPPORT USED A REMOTE ELECTRONIC CONNECTION METHOD TO ASSESS THE TEST WELL IMAGES ON THE ECHO. PI LAB PERFORMED A WEAK_D ASSAY ON THREE KNOWN RH NEGATIVE IN HOUSE DONOR SAMPLES AND 1 RH POSITIVE SAMPLE ON THE ECHO USING RETENTION CAPTURE-SELECT PLATES LOT SC284 AND RETENTION CAPTURE-R INDICATOR CELLS LOT 221236. CONTROLS PERFORMED AS EXPECTED AND ALL RH NEGATIVE IN HOUSE DONOR SAMPLES WERE NEGATIVE AS EXPECTED RETENTION PRODUCT PERFORMED AS EXPECTED. A SERVICE CALL WAS MADE TO CHECK THE PROBE AUTOCAL SETTING. CUSTOMER REPORTS USING A NEW LOT OF CAPTURE-R SELECT , SC294, HAS RESOLVED THE PROBLEM. CUSTOMER INDICATES AFFECTED SAMPLES WERE REPEATED AND REPORTED OUT NEGATIVE WITH CELL BUTTONS APPEARING AS EXPECTED. OUR INVESTIGATION DID NOT IDENTIFY A POTENTIAL PRODUCT DEFICIENCY. THE CUSTOMER ISSUE WAS NOT REPRODUCED OR CONFIRMED.

    Description of Event or Problem · 1

    ON (B)(6) 2014 A CUSTOMER REPORTS A DONOR UNIT WHICH IS O RH NEGATIVE REPORTED OUT AS RH POSITIVE ON WEAK D TESTING USING CAPTURE-R SELECT PLATES ON THE GALILEO ECHO INSTRUMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    644264 CAPTURE-R SELECT REAGENT RED BLOOD CELLS KSZ IMMUCOR, INC. SC284

    Patients

    Seq Age Sex Outcome Treatment
    1