BEUDAMED
    FDA Adverse Event Death Summary report: N

    ACL ADVANCE

    MDR report key: 588601 · Received April 5, 2005

    Report

    Report Number
    1217183-2005-00001
    Event Type
    Death
    Date Received
    April 5, 2005
    Report Date
    April 4, 2005
    Manufacturer
    INSTRUMENTATION LABORATORY CO.
    Product Code
    JPA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    ALTHOUGH THE FOLLOWING INCIDENT OCCURRED IN NOVEMBER 2004, IT WAS NOT REPORTED TO AN INSTRUMENTATION LABORATORY CO.EMPLOYEE UNTIL MARCH 2005. PER THE CUSTOMER, THE INCIDENT INVOLVED TWO PATIENT DEATH IN A SHORT PERIOD OF TIME FROM INCORRECT HEPARIN DOSAGES. APPARENTLY, THE STAFF DID NOT FOLLOW THEIR PROTOCOL TO CHECK FOR ANY PENDING RESULTS/SAMPLES RUNS EVERY HOUR, WHICH RESULTED IN GREATLY PROLONGED REPORTING OF RESULTS. AS A CONSEQUENCE, THE NURSING STAFF ERRONEOUSLY ADMINISTERED ONE PATIENT 100X AND ANOTHER PATIENT 1000X THE USUAL HEPARIN DOSAGE. THE APTT SAMPLE WAS DRAWN AFTER AT LEAST ONE OF THESE INCORRECT DOSAGES OF HEPARIN WAS GIVEN. THE ACL ADVANCE IN USE AT THE TIME GAVE "COAG ERRORS" FOR THESE PATIENTS WITH NO ERRONEOUS RESULTS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ACL ADVANCE COAGULATION ANALYZER JPA INSTRUMENTATION LABORATORY CO. ADVANCE NA

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN Death