BEUDAMED
    FDA Adverse Event Other Summary report: N

    ACL 100

    MDR report key: 440065 · Received January 23, 2003

    Report

    Report Number
    1217183-2003-00001
    Event Type
    Other
    Date Received
    January 23, 2003
    Report Date
    January 23, 2003
    Manufacturer
    INSTRUMENTATION LABORATORY CO.
    Product Code
    GKP
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OK, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    A CUSTOMER COMPLAINT WAS RECEIVED THROUGH COMPANY'S PRODUCT DISTRIBUTOR THAT THEIR ACL 100 COAGULATION ANALYZER WAS REPORTING LOW INRS (INTERNATIONAL NORMALIZED RATIOS). A SERVICE ENGINEER IDENTIFIED THAT THE CUSTOMER'S INSTRUMENT INR SETTING WAS TURNED OFF AND THEY HAD BEEN REPORTING RATIO RESULTS AS INRS. THEY OBSERVED THAT INSTRUMENT PRINTOUTS DATED BACK TO 07/02/02 SHOWING THE INR OFF. FURTHER REVIEW OF SERVICE HISTORY SHOWS THE INSTRUMENT'S VDU WAS REPLACED IN JULY OF 2002. THE COMPLAINT TEXT STATED THAT THERE WERE NO KNOWN INJURIES OR DEATHS ASSOCIATED WITH THE ABOVE EVENT. HOWEVER, IN FOLLOW-UP COMMUNICATION WITH THE CUSTOMER, IT WAS NOTED THAT A PATIENT AT THEIR FACILITY WITH ELEVATED INRS WAS TRANSFERRED TO A NEARBY HOSPITAL WHERE PT LATER DIED. NOTE: THERE IS NO AVAILABLE EVIDENCE THAT THE PT'S DEATH IS RELATED TO THE INCIDENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ACL 100 AUTOMATED COAGULATION INSTRUMENT GKP INSTRUMENTATION LABORATORY CO. 100 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN Other