BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    0.8% SELECTOGEN FOR GEL

    MDR report key: 4181548 · Received October 17, 2014

    Report

    Report Number
    2250051-2014-00108
    Event Type
    Malfunction
    Date Received
    October 17, 2014
    Date of Event
    July 17, 2014
    Report Date
    October 17, 2014
    Manufacturer
    ORTHO CLINICAL DIAGNOSTICS
    Product Code
    KSZ
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OK, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    OCD HAD PREVIOUSLY PERFORMED RETAIN TESTING, BATCH REVIEW AND COMPLAINT REVIEW BY LOT. FURTHER INVESTIGATION WAS PERFORMED AND DONOR HISTORY REVIEWED. ALTHOUGH RETAIN TESTING PASSED ALL RELEASE CRITERIA, DONOR WAS PERMANENTLY DEFERRED FROM FURTHER USE. CUSTOMER LETTER WAS ISSUED TO ALL CUSTOMERS WHO RECEIVED LOT# VS748. THIS COMPLAINT WAS RECEIVED AS A RESULT OF THE CUSTOMER LETTER AND AS THE CUSTOMER WAS UNWILLING TO INVESTIGATE FURTHER, THE IDENTITY OF THE MISSED ANTIBODY IS NOT KNOWN.

    Description of Event or Problem · 1

    OCD WAS INFORMED VIA EMAIL OF A POTENTIAL ISSUE REGARDING A PATIENT THAT MIGHT HAVE HAD A FALSE NEGATIVE ANTIBODY SCREEN WHEN TESTED WITH 0.8% SELECTOGEN LOT VS748. OCD CALLED THE CUSTOMER DIRECTLY TO OBTAIN EXACT DETAILS OF THE POTENTIAL EVENT. CUSTOMER STATED SHE BECAME AWARE OF THE ISSUE AFTER READING OCD CUSTOMER LETTER (B)(4). THE ANTIBODY SCREEN TEST THAT IS IN QUESTION WAS PERFORMED ON (B)(6) 2014 AND INVOLVED ONE B POSITIVE MALE PATIENT. THIS PATIENT RECEIVED 2 B POSITIVE BLOOD UNITS THAT WERE CROSSMATCH COMPATIBLE. THE UNITS WERE CROSSMATCHED BY IMMEDIATE SPIN AS WELL AS A FULL CROSSMATCH (INCUBATED FOR 15 MIN AT 37 DEGREES CELSIUS) IN IGG GEL CARD. THE BLOOD TRANSFUSION WAS UNEVENTFUL; PATIENT TOLERATED THE UNITS AND SHOWED NO SIGNS/SYMPTOMS OF A REACTION. SOME WEEKS LATER, THE PATIENT WAS TREATED AT A DIFFERENT HOSPITAL AND THIS FACILITY CALLED CUSTOMER TO INQUIRE ABOUT TRANSFUSION HISTORY ON THE PATIENT SINCE THEIR ANTIBODY SCREEN TEST WAS POSITIVE. NO ADDITIONAL INFORMATION WAS PROVIDED REGARDING THE ANTIBODY IDENTIFIED. CUSTOMER DECLINED REQUEST FOR FOLLOW UP WITH THE OTHER HOSPITAL. CUSTOMER IS NOT WILLING TO INVESTIGATE FURTHER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    661829 0.8% SELECTOGEN FOR GEL REAGENT RED BLOOD CELLS KSZ ORTHO CLINICAL DIAGNOSTICS VS748

    Patients

    Seq Age Sex Outcome Treatment
    1