BEUDAMED
    FDA Adverse Event Other Summary report: N

    ACL 8000

    MDR report key: 779088 · Received August 30, 2006

    Report

    Report Number
    1217183-2006-00003
    Event Type
    Other
    Date Received
    August 30, 2006
    Date of Event
    August 1, 2006
    Report Date
    August 30, 2006
    Manufacturer
    INSTRUMENTATION LABORATORY CO.
    Product Code
    JPA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THIS COMPLAINT IS CURRENTLY UNDER INVESTIGATION. ALTHOUGH THE RAW OPTICAL DATA WERE NOT AVAILABLE, IL IS REVIEWING THE AVAILABLE DATA FROM THE INSTRUMENT TO DETERMINE IF A REPORTABLE EVENT OCCURRED. IF REMEDIAL ACTION IS REQUIRED BASED ON THE INVESTIGATION, THEN A FOLLOW-UP REPORT WILL BE FILED.

    Description of Event or Problem · 1

    A CUSTOMER COMPLAINT WAS RECEIVED INDICATING THAT THEIR ACL 8000 REPORTED AN INCORRECT PROTHROMBIN TIME (PT) RESULT WITHOUT AN ERROR FLAG ON A PATIENT SAMPLE. TWO PREVIOUS PT RESULTS ON THE SAME PATIENT SAMPLE REPORTED WITH NOISY BASELINE ERROR FLAGS. THE INCORRECT PT RESULT REPORTED ON THE ACL 8000 AS 20.6 SECONDS WITH AN INR OF 1.97 (ISI = 1.11; MEAN NORMAL RANGE = 11.2). THE CUSTOMER SENT THE SAMPLE TO ANOTHER LAB AND THEIR RESULT WAS 51.6 SECONDS WITH AN INR OF 14 (ISI = 1.78; MEAN NORMAL RANGE = 11.8). PER THE CUSTOMER, THE INCORRECT RESULT FROM THE ACL 8000 WAS REPORTED TO THE PHYSICIAN SINCE IT WAS NOT FLAGGED. HOWEVER, NO ADVERSE EVENT WAS ATTRIBUTED IN THE COMPLAINT DUE TO THE RESULT. NOTES: BASED ON THE TWO PREVIOUS FLAGGED SAMPLES, HAD THE CUSTOMER REVIEWED THE CURVE OF THE THIRD SAMPLE, THEY WOULD HAVE LIKELY REALIZED THAT THE RESULT WAS INCORRECTLY REPORTED. THE SAMPLE IN QUESTION WAS CHARCTERIZED IN THE COMPLAINT AS 1 + LIPEMIA, INDICATING POTENTIAL OPTICAL INTERFERENCE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ACL 8000 COAGULATION ANALYZER JPA INSTRUMENTATION LABORATORY CO. 8000 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN