BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACL ELITE

    MDR report key: 1942356 · Received December 22, 2010

    Report

    Report Number
    1217183-2010-00002
    Event Type
    Malfunction
    Date Received
    December 22, 2010
    Date of Event
    October 26, 2010
    Report Date
    December 22, 2010
    Manufacturer
    INSTRUMENTATION LABORATORY CO.
    Product Code
    JPA
    PMA / PMN Number
    K060162
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CT, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    ISSUE DESCRIPTION: KNOWN ISSUE OF SPORADICALLY LOWERED APTT RESULTS OUTSIDE OF THE CLIA ALLOWABLE ERROR LIMIT OF 15% WHEN USING IL LOCKED PT/APTT TEST GROUPS ON THE ACL ELITE (B)(6). ROOT CAUSE: PT REAGENT CARRYOVER IN THE TEST GROUP MODE IS A POSSIBLE CONTRIBUTING FACTOR IN THE OCCURRENCES OF THE LOWER APTT VALUES. RECALL IN-PROCESS: A RECALL IS CURRENTLY UNDERWAY ON THIS INSTRUMENT FAMILY (REFERENCE INTERNAL RECALL NO. RECALL 2010-012-C). THE RECALL IS BEING TRACKED THROUGH THE LOCAL (B)(6) FDA DISTRICT OFFICE (B)(6) AND (B)(6). NOTE: FDA ASSIGNED RECALL NO. PENDING. CUSTOMER HAVE BEEN ISSUED AN URGENT PRODUCT NOTIFICATION ADVISING THEM TO DISCONTINUE USE OF ALL IL LOCKED PT/APTT-BASED TEST GROUPS AND TO ONLY RUN THEIR INSTRUMENT IN SINGLE TEST OR PROFILE MODE UNTIL FURTHER NOTICE. NOTE: THIS COMPLAINT PRE-DATES THE ISSUANCE OF THE NOTIFICATION TO US CUSTOMERS (MAILED ON (B)(6) 2010).

    Description of Event or Problem · 1

    CUSTOMER COMPLAINT REPORTED SPORADICALLY SHORTENED APTT RESULTS WHEN USING THE RPT-SYS TEST GROUP MODE ON THEIR ACL ELITE COAGULATION ANALYZER. THE INITIAL APTT (SYS) RESULTS WERE SHORTER THAN REPEAT RESULTS. CLOT CURVES APPEAR APPROPRIATE WITH NO ERRORS OR WARNINGS. THERE WAS NO CHANGE TO PT TREATMENT AS A RESULT OF THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ACL ELITE COAGULATION ANALYZER JPA INSTRUMENTATION LABORATORY CO. 8803-11 NA

    Patients

    Seq Age Sex Outcome Treatment
    1