BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACL TOP 700 LAS

    MDR report key: 3117958 · Received May 7, 2013

    Report

    Report Number
    1217183-2013-00010
    Event Type
    Malfunction
    Date Received
    May 7, 2013
    Date of Event
    January 18, 2013
    Report Date
    January 30, 2013
    Manufacturer
    INSTRUMENTATION LABORATORY (IL) CO.
    Product Code
    GKP
    PMA / PMN Number
    K091980
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    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 REPORTED INTERMITTENTLY LOWERED NORMAL AND ABNORMAL CONTROL RESULTS WITH HEMOSIL SYNTHASIL (APTT ASSAY) ON THEIR ACL TOP 700 LAS INSTRUMENT. WHEN THE REAGENTS WERE REPLACED, THE QC PASSED. SERVICE WAS PERFORMED. HOWEVER, THE ISSUE REOCCURRED. TYPICALLY, THE NORMAL CONTROL IS 6 SECONDS LOW AND THE ABNORMAL CONTROL IS 15 SECONDS LOW. THERE WAS NO REPORTED ADVERSE EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    199951 ACL TOP 700 LAS COAGULATION ANALYZER GKP INSTRUMENTATION LABORATORY (IL) CO. 2800-30 NA

    Patients

    Seq Age Sex Outcome Treatment
    1