BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CAPTURE-R SELECT

    MDR report key: 2841353 · Received November 21, 2012

    Report

    Report Number
    1034569-2012-00215
    Event Type
    Malfunction
    Date Received
    November 21, 2012
    Date of Event
    October 4, 2012
    Report Date
    November 21, 2012
    Manufacturer
    IMMUCOR, INC.
    Product Code
    KSS
    PMA / PMN Number
    BK040024
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    MEDICAL TECHNOLOGIST

    Narratives

    Additional Manufacturer Narrative · 1

    THE CUSTOMERS SUBMITTED SAMPLE RESULTED AS POSITIVE (2+ INCOMPATIBLE) WITH THREE SUBMITTED DONOR SAMPLES AND INVALID WITH ONE SUBMITTED DONOR SAMPLE DUE TO A MONOLAYER FAILURE. KNOWN ANTI-JKB POSITIVE AND NEGATIVE SAMPLES WERE CROSSMATCHED WITH THE FOUR SUBMITTED DONOR SAMPLES AND THE EXPECTED POSITIVE (3+) AND NEGATIVE RESULTS WERE OBTAINED. THE CROSSMATCH ASSAY WAS REPEATED THREE MORE TIMES WITH THE SUBMITTED SAMPLE; IT WAS NOT POSSIBLE TO OBTAIN A CROSSMATCH RESULT FOR SAMPLE (B)(4) WITH DONOR (B)(6) DUE TO MONOLAYER FAILURES.

    Description of Event or Problem · 1

    A CUSTOMER REPORTED OBTAINING AN UNEXPECTED NEGATIVE REACTION WITH THE CROSSMATCH ASSAY WITH A KNOWN ANTI-JKB SAMPLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CAPTURE-R SELECT BLOOD BANK SUPPLY KSS IMMUCOR, INC. SC208

    Patients

    Seq Age Sex Outcome Treatment
    1