BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACL TOP

    MDR report key: 3117956 · Received May 7, 2013

    Report

    Report Number
    1217183-2013-00012
    Event Type
    Malfunction
    Date Received
    May 7, 2013
    Date of Event
    November 23, 2012
    Report Date
    February 25, 2013
    Manufacturer
    INSTRUMENTATION LABORATORY (IL) CO.
    Product Code
    GKP
    PMA / PMN Number
    K073377
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PO
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THIS COMPLAINT WAS ORIGINALLY ASSESSED TO NOT QUALIFY AS A POTENTIALLY REPORTABLE INCIDENT. HOWEVER, BASED ON FURTHER INFO REVIEWED FOR POTENTIAL RISK ON (B)(4) 2013, THIS COMPLAINT WAS DETERMINED TO BE REPORTABLE AND IS CURRENTLY UNDER INVESTIGATION. A F/U REPORT WILL BE FILED ONCE A CONCLUSION IS DETERMINED FROM THIS INVESTIGATION.

    Description of Event or Problem · 1

    CUSTOMER REPORTS LOWERED APTT RESULTS WHEN RUNNING HEMOSIL SYNTHASIL (APTT ASSAY) ON THEIR ACL TOP INSTRUMENT. WHEN THE SAMPLE IS RUN AGAIN WITH NO REAGENT CHANGE, THE RESULT IS NORMAL. THEY OBSERVE THAT WHEN CONTROLS ARE RUN IN DUPLICATE, THE % MAXIMUM DIFFERENCE FOR THE REPLICATES IS EXCEEDED. FLAG = %MAX DIFFERENCE OF REPS EXCEEDED. SAMPLE (B)(6) REPEATED. THERE WAS NO REPORTED ADVERSE EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    200073 ACL TOP COAGULATION ANALYZER GKP INSTRUMENTATION LABORATORY (IL) CO. 2800-11 NA

    Patients

    Seq Age Sex Outcome Treatment
    1