BEUDAMED
    FDA Adverse Event Other Summary report: N

    *

    MDR report key: 761530 · Received October 20, 2005

    Report

    Report Number
    1037985-2005-00004
    Event Type
    Other
    Date Received
    October 20, 2005
    Manufacturer
    *
    Product Code
    JTC
    Report Source
    Manufacturer report
    Reporter Occupation
    INVALID DATA

    Narratives

    Additional Manufacturer Narrative · 1

    THE CUSTOMER CONDUCTED AN ANTIBODY SCREEN TESTING WITH A KNOWN ANTI-C PT. THE TEST WAS PREPARED BY THE TECAN MEGAFLEX AND THE RESULTS ANALYZED BY THE IMPORTER'S READER SA. ANTI-C WAS IDENTIFIED ON THE FIRST TEST, ON 8/21/2005. WHEN A NEW SAMPLE WAS TESTED ON 8/23/2005 WITH THE TECAN MEGAFLEX AND THE READER SA, THE ANTIBODY SCREEN TEST WAS NEGATIVE. THE TEST WAS REPEATED WITH THE SAME RESULT. MANUAL TESTING REVEALED A POSITIVE REACTION FOR THE ANTIBODY SCREEN. NO ERRONEOUS RESULTS WERE RELEASED; NO PT IMPACT. A FIELD ENGINEER WAS DISPATCHED TO THE SITE ON 08/25/2005 AND COULD NOT IDENTIFY A PROBLEM WITH THE INSTRUMENT. THE USER REPORTED ON 08/26/2005 THAT THE TECAN PIPETTE TIPS WERE NOT ALIGNED. A FIELD ENGINEER REPAIRED THE INSTRUMENT ON 08/30/2005.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 * * JTC * * *

    Patients

    Seq Age Sex Outcome Treatment
    1 *