BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DPB1 SSP UNITRAY KIT

    MDR report key: 3558181 · Received October 15, 2013

    Report

    Report Number
    2244574-2013-00061
    Event Type
    Malfunction
    Date Received
    October 15, 2013
    Report Date
    October 9, 2012
    Manufacturer
    LIFE TECHNOLOGIES CORP.
    Product Code
    MZI
    PMA / PMN Number
    BK020068
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    VA, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    THE INTERNAL INVESTIGATION DETERMINED THE ROOT CAUSE OF THE MISSING SEROLOGICAL EQUIVALENT INFORMATION WAS A RESULT OF THE JULY 2012 UPDATE TO THE ALLELE LIST INFORMATION CONTAINED WITH THE DPB1 SSP UNITRAY KIT. THE SOURCE OF THE SEROLOGICAL EQUIVALENT DESIGNATIONS WAS MODIFIED TO PROVIDE THE MOST CURRENT INFORMATION WITHIN THE SSP KITS. THE WORKSHEET DOCUMENT CONTAINED WITHIN THE DPB1 SSP UNITRAY KIT (CATALOG # 451606D, LOT # 008 1103716) DID NOT CONTAIN THE SEROLOGICAL EQUIVALENT INFORMATION SINCE THAT INFORMATION WAS NOT PRESENT IN THE SEROLOGICAL EQUIVALENT SOURCE FILE USED AS PART OF THE JULY 2012 ALLELE UPDATE. A CHANGE TO THE WORKSHEET DOCUMENT WAS COMPLETED TO ADD THE SEROLOGICAL EQUIVALENT INFORMATION. CUSTOMER NOTIFICATIONS REGARDING REPORTING OF THE SEROLOGICAL EQUIVALENT INFORMATION, INCLUDING THE SOURCES FOR THE SEROLOGICAL EQUIVALENT DATA AND INSTRUCTION FOR OBTAINING UPDATED WORKSHEETS AND UPDATED UNIMATCH SOFTWARE .UCH FILES WERE DISTRIBUTED. NO IMPACT TO PATIENT MANAGEMENT WAS REPORTED. THIS IS THE INITIAL AND FINAL REPORT.

    Description of Event or Problem · 1

    (B)(6) WITH (B)(6) HOSPITAL INDICATED THAT MULTIPLE SSP KITS, WHEN USED WITH UNIMATCH SOFTWARE, WERE EXHIBITING INCORRECT OF DIFFERING INFORMATION FOR SEROLOGIC EQUIVALENTS OF HLA ALLELES. SHE ALSO INDICATED THE SEROLOGIC EQUIVALENTS FOR A DPB1 02, DPB1 04 WERE NO LONGER INCLUDED IN THE DPB1 SSP UNITRAY KIT DOCUMENTATION (CATALOG #451606D, LOT # 008 1103716). ((B)(4)).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    528407 DPB1 SSP UNITRAY KIT MZI LIFE TECHNOLOGIES CORP. 008 1103716

    Patients

    Seq Age Sex Outcome Treatment
    1