BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BIOTESTCELL-I8

    MDR report key: 2149039 · Received June 10, 2011

    Report

    Report Number
    9610824-2011-00078
    Event Type
    Malfunction
    Date Received
    June 10, 2011
    Date of Event
    April 26, 2011
    Report Date
    June 10, 2011
    Manufacturer
    BIO-RAD MEDICAL DIAGNOSTICS GMBH
    Product Code
    KSZ
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AU
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED A FALSE NEGATIVE REACTION OF AN ANTI-D WITH CELL 1 OF BIOTESTCELL-I8 ART.-(B)(4), LOT 2113011. THIS ISSUE WAS DOCUMENTED AS A COMPLAINT AT BEGINNING OF (B)(6). AT THAT TIME THE COMPLAINED LOT OF BIOTESTCELL-I8 WAS ALREADY EXPIRED. THEREFORE A TESTING OF THE COMPLAINED SAMPLE AND THE RETENTION SAMPLE WAS NOT POSSIBLE. THE CUSTOMER USED THE COMPLAINED PRODUCT BIOTESTCELL-I8 FOR AN IDENTIFICATION OF ANTIBODIES IN THE GEL METHOD. BUT ACCORDING TO THE INSTRUCTION FOR USE THE INTENDED USE OF THE PRODUCT ARE THE TUBE TEST AND THE SOLIDPHASE TEST SOLIDSCREEN II. IN THE INSTRUCTION FOR USE OF BIOTESTCELL-I8 IT IS POINTED OUT THAT "EACH DEVIATION FROM THESE INSTRUCTIONS IS THE SOLE RESPONSIBILITY OF THE USER". AND FURTHER "THE USE IN OTHER AUTOMATED SYSTEMS IS TO BE VALIDATED BY THE USER". NONETHELESS SUCH CASES WILL IN FUTURE BE OUTRIGHTLY HANDLED AS INCIDENTS. THE EMPLOYEES IN CHARGE WERE INSTRUCTED ACCORDINGLY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 BIOTESTCELL-I8 BIOTESTCELL-I8 KSZ BIO-RAD MEDICAL DIAGNOSTICS GMBH 2113011

    Patients

    Seq Age Sex Outcome Treatment
    1