BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ACL TOP 500 CTS

    MDR report key: 7038808 · Received November 16, 2017

    Report

    Report Number
    1217183-2017-00006
    Event Type
    Injury
    Date Received
    November 16, 2017
    Date of Event
    October 20, 2017
    Report Date
    November 16, 2017
    Manufacturer
    INSTRUMENTATION LABORATORY CO.
    Product Code
    GKP
    UDI-DI
    08426950453499
    PMA / PMN Number
    K160276
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE INCIDENT IS CURRENTLY UNDER INVESTIGATION WITH NO MALFUNCTION IDENTIFIED TO DATE. A FOLLOW-UP REPORT WILL BE SUBMITTED WHEN THE COMPLAINT INVESTIGATION IS COMPLETED.

    Additional Manufacturer Narrative · 1

    CUSTOMER REPORTED THAT THEIR ACL TOP 500 CTS REPORTED ERRONEOUS APTT PATIENT RESULTS USING HEMOSIL SYNTHASIL. SIX PATIENT SAMPLES GENERATED ERRONEOUS RESULTS. ALL SIX SAMPLES WERE SUBSEQUENTLY CORRECTED. ONE PATIENT RECEIVED A BOLUS OF HEPARIN. THE PATIENT DEVELOPED A SUPERFICIAL RIGHT GROIN HEMATOMA. THE CUSTOMER WAS UNABLE TO DETERMINE IF THIS WAS A RESULT OF THE BOLUS OF HEPARIN. SERVICE WAS DISPATCHED TO THE SITE TO INSPECT THE INSTRUMENT. NO VISUAL PROBLEMS WERE OBSERVED, ALL PERFORMANCE CHECKS PASSED, AND QUALITY CONTROL WAS ACCEPTABLE INDICATING THAT THE INSTRUMENT WAS PERFORMING AS EXPECTED. A REVIEW OF THE SUBMITTED INSTRUMENT BACKUP WAS PERFORMED AND DATA FOR THE PATIENT RECEIVING THE BOLUS OF HEPARIN COULD BE FOUND, HOWEVER, THE OTHER RESULTS COULD NOT BE LOCATED BASED ON THE IDENTIFIERS PROVIDED. IT CAN BE DETERMINED THAT THE PATIENT SAMPLE GENERATED A RESULT OF 58.6 SECONDS WITHOUT ERRORS OR WARNINGS AND THEN GENERATED RESULTS OF GREATER THAN 200 SECONDS APPROXIMATELY TWO HOURS LATER. WHILE THE ROOT CAUSE CANNOT BE DETERMINED, THERE ARE MANY VARIABLES THAT HAVE THE POTENTIAL TO INFLUENCE THE RESULT RECOVERIES. THESE MAY INCLUDE BUT ARE NOT LIMITED TO, THE ON-BOARD STABILITY OF THE REAGENT AND CLEANING MATERIALS, SAMPLE COLLECTION AND PROCESSING, INSTRUMENT MAINTENANCE, AND SERVICE, ETC.

    Description of Event or Problem · 1

    CUSTOMER REPORTED THAT THEIR ACL TOP 500 CTS REPORTED ERRONEOUS APTT RESULTS FOR 6 PATIENTS USING HEMOSIL SYNTHASIL. ALL 6 PATIENT SAMPLE RESULTS WERE RE-RUN AND CORRECTED. ONE PATIENT (CH) WAS ADMINISTERED A BOLUS OF HEPARIN. CH DEVELOPED A SUPERFICIAL RIGHT GROIN HEMATOMA. THE CUSTOMER WAS UNABLE TO DETERMINE IF THIS WAS A RESULT OF THE BOLUS OF HEPARIN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    815937 ACL TOP 500 CTS ACL TOP GKP INSTRUMENTATION LABORATORY CO. 2800-40 08426950453499

    Patients

    Seq Age Sex Outcome Treatment
    1 Other