BEUDAMED
    FDA Adverse Event Summary report: N

    ACL ADVANCE

    MDR report key: 730765 · Received July 13, 2005

    Report

    Report Number
    1217183-2005-00004
    Date Received
    July 13, 2005
    Report Date
    July 13, 2005
    Manufacturer
    INSTRUMENTATION LABORATORY CO.
    Product Code
    JPA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    H3: THE PRINTOUT OF THE CLOT CURVE FROM THE ACL ADVANCE FOR THE PATIENT SAMPLE RESULT IN QUESTION WAS OBTAINED FROM THE SITE AND REVIEWED INTERNALLY. H6: AN INTERNAL INVESTIGATION CONCLUDED THAT THE PARAMETER APPLICATION FOR HEMOSIL RECOMBIPLASTIN ON THE ACL FUTURA AND ACL ADVANCE NEED TO BE REFINED TO EXTEND THE ACQUISTION TIME TO DEFINE THE CLOT POINT OF SAMPLES WITH VERY HIGH INR VALUES (ABOVE THE THERAPEUTIC RANGE). H7: INTERIM CORRECTIVE ACTION (MAY 2005): AN "URGENT PRODUCT NOTIFICATION" WAS DISTRIBUTED, ADVISING CUSTOMERS TO REVIEW THE PT CURVE FOR ANY PATIENT ON ANTICOAGULANT TREATMENT WHO REPORTS A LOW RESULT INCONSISTENT WITH THE PATIENT CONDITION OR THERAPY. LONG-TERM (JULY 2005): THE TESTING OF THE REFINED PARAMETERS WITH THE EXTENDED ACQUISTION TIME FOR HEMOSIL RECOMBIPLASTIN ON THE ACL ADVANCE IS COMPLETE. THE RELEASE OF THE PARAMETERS IS EXPECTED THE WEEK OF JULY 18 AND THE MANDATORY UPGRADE WILL BE TRACKED IN THE FIELD TO A 100% RESPONSE RATE. THIS REGULATORY ACTION WAS NOTIFIED INTO THE LOCAL FDA OFFICE.

    Description of Event or Problem · 1

    ACL ADVANCE COAGULATION ANALYZER DID NOT FLAG AN ERRONEOUS PROTHROMBIN TIME (PT) RESULT. THE PT REAGENT IN USE WAS HEMOSIL RECOMBIPLASTIN [510(K) NO. K041381]. IN THIS RARE OCCURRENCE, THE ACQUISTION TIME (STANDARD AND/OR EXTENDED) DID NOT ALLOW SUFFICIENT TIME TO ACQUIRE DATA AND THEREFORE, THE BASELINE NOISE MET THE CRITERIA TO DEFINE THE CLOT POINT. A REVIEW OF THE CLOT CURVE PRINTOUT FOR THIS RESULT SHOWED IT TO BE CLEARLY ABNORMAL. NOTE: TO OUR KNOWLEDGE, PATIENT THERAPY WAS NOT ALTERED AS A RESULT OF THIS OCCURRENCE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ACL ADVANCE SYSTEM, MULTIPURPOSE FOR IN VITRO COAGULATION STUDIES JPA INSTRUMENTATION LABORATORY CO. ADVANCE NA

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN