BEUDAMED
    FDA Adverse Event Death Summary report: N

    ACL TOP 500

    MDR report key: 3760662 · Received April 11, 2014

    Report

    Report Number
    1217183-2014-00003
    Event Type
    Death
    Date Received
    April 11, 2014
    Date of Event
    March 9, 2014
    Report Date
    March 13, 2014
    Manufacturer
    INSTRUMENTATION LABORATORY CO.
    Product Code
    GKP
    PMA / PMN Number
    K07337
    Report Source
    Manufacturer report
    Reporter Location
    ME, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    AN INTERNAL EVALUATION HAS BEEN PERFORMED WITH THE REAGENT LOT OF HEMOSIL Q.F.A. THROMBIN IN USE AT THE CUSTOMER SITE. THE EVALUATION SHOWED THAT THE TEST SUCCESSFULLY CALIBRATED AND RECOVERED MEANS FOR ALL CONTROL SETS WITHIN THEIR RANGES. TO COMPLETE THE INVESTIGATION, INSTRUMENTATION LABORATORY CO. IS AWAITING THE DATA BACK-UP FROM THE ACL TOP 500 CTS IN USE AT THE CUSTOMER SITE. SEVERAL REQUESTS HAVE BEEN MADE FOR THE BACK-UP AND WE WILL SUBMIT A FOLLOW-UP REPORT WHEN THIS ADDITIONAL INFO IS RECEIVED. THERE IS NO INDICATION TO DATE THAT THE HEMOSIL Q.F.A. THROMBIN RESULT WAS A CONTRIBUTING FACTOR IN THE PT DEATH.

    Description of Event or Problem · 1

    ON (B)(6) 2014, THE CUSTOMER CALLED TO QUESTION A PT'S CLAUSS FIBRINOGEN RESULT USING HEMOSIL Q.F.A. THROMBIN ON THEIR ACL TOP 500 CTS INSTRUMENT. THE SAMPLE WAS DRAWN ON (B)(6) 2014, AND GAVE A FIBRINOGEN RESULT OF 183 MG/DL. DAILY MAINTENANCE WAS PERFORMED ON THE INSTRUMENT AND QC WAS IN RANGE BEFORE AND AFTER THE SAMPLE WAS DRAWN. THE SAMPLE WAS DRAW AT 12:10 PM AND FROZEN AT 2:00 PM. THE FROZEN SAMPLE WAS DEFROSTED FOUR DAYS POST DRAW AND THAWED AT 37 DEGREES CELSIUS FOR FOUR MINUTES. THE THAWED, DILUTED, SAMPLE WAS RUN IN THE Q/F/A/ TEST AT 11/35 ON 03/13 AND FAILED. TI WAS THEN TESTED AGAIN AS A NEAT SAMPLE AT 11:36 AND A RESULT OF 332 MG/DL WAS OBTAINED. THE SAMPLE WAS THEN TESTED IN THE Q.F.A. LOW TEST AND A RESULT OF 67 MG/DL WAS OBTAINED. THE PT DIED ON (B)(6) 2014. THERE IS NO INDICATION FROM THE CUSTOMER THAT THE FIBRINOGEN RESULT OF 183 MG/DL WAS RELATED TO THE PT DEATH.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    220662 ACL TOP 500 COAGULATION ANALYZER GKP INSTRUMENTATION LABORATORY CO. 2800-40 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 Death