BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    I-STAT TROPONIN (CTNI) CARTRIDGE

    MDR report key: 2446499 · Received January 19, 2012

    Report

    Report Number
    2245578-2012-00024
    Event Type
    Malfunction
    Date Received
    January 19, 2012
    Date of Event
    September 13, 2011
    Report Date
    December 20, 2011
    Manufacturer
    ABBOTT POINT OF CARE INC.
    Product Code
    MMI
    PMA / PMN Number
    K031739
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CO, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). AN INVESTIGATION WAS COMPLETED (B)(4) 2011. RETAIN TESTING ON THE SAME LOTS THAT WERE TESTED BY THE CUSTOMER AT 10,000 FEET WERE ALSO TESTED AT GROUND LEVEL IN (B)(6) (374 FEET ABOVE SEA LEVEL). ON THE GROUND, THE LOTS HAD ZERO DETECTED ERRORS OUT OF 20 CARTRIDGES TESTED FROM EACH LOT. A LARGER STUDY WAS INITIATED TO BETTER UNDERSTAND AND DETERMINE THE EFFECT OF ALTITUDE ON QUALITY CHECK CODES (ANALYZER DETECTED ERRORS) ON T LOTS OF TROPONIN. CARTRIDGE LOTS TESTED AT 5,000 AND 10,000 FEET ABOVE SEA LEVEL SHOWED INCREASE RATES OF ANALYZER DETECTED ERRORS. RETURN PRODUCT TESTING HAD BEEN PERFORMED PRIOR TO THE RECOGNITION THAT ALTITUDE MAY BE A FACTOR IN THE CUSTOMER OBSERVATIONS OF INCREASED QUALITY CHECK CODE RATES AND THE CUSTOMER COMPLAINT WAS NOT REPRODUCED.

    Description of Event or Problem · 1

    ON (B)(6) 2011, ABBOTT POINT OF CARE WAS CONTACTED BY A CUSTOMER REGARDING I-STAT TROPONIN CARTRIDGES THAT ARE YIELDING A HIGH RATE FOR QUALITY CHECK CODES (QCC) 123, 126 AND 142 ON A PATIENT. THE CUSTOMER SUSPECTS THAT ALTITUDE MAY BE THE CAUSE. THE CUSTOMER STATES THAT THE EQUIPMENT IS PERFORMING AS INTENDED WITH OTHER TYPES OF CARTRIDGES. BASED ON THE INFORMATION AVAILABLE, THERE WERE NO INJURIES ASSOCIATED WITH THIS EVENT. LOT#: T11129B, MANUFACTURED: 05/09/2011, EXPIRES: 11/28/2011. NOTE: ALL "T" LOTS ASSOCIATED WITH THIS INCIDENT HAVE EXPIRED AND PREVIOUSLY ASSOCIATED WITH AN UNRELATED CORRECTIVE ACTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 I-STAT TROPONIN (CTNI) CARTRIDGE CTNI CARTRIDGE MMI ABBOTT POINT OF CARE INC. NA T11129B

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK