BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    I-STAT TROPONIN (CTNI) CARTRIDGE

    MDR report key: 2462078 · Received February 14, 2012

    Report

    Report Number
    2245578-2012-00050
    Event Type
    Malfunction
    Date Received
    February 14, 2012
    Date of Event
    August 23, 2011
    Report Date
    February 2, 2012
    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) 2012. RETAIN TESTING FOR LOTS T11118 AND T11124 WERE PART OF A LARGER STUDY THAT 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 5000 AND 10000 FEET ABOVE SEA LEVEL SHOWED INCREASE RATES OF ANALYZER DETECTED ERRORS.

    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 STATS THAT THE EQUIPMENT IS PERFORMING AS INTEND WITH OTHER TYPES OF CARTRIDGES. BASED ON THE INFORMATION AVAILABLE, THERE WERE NO INJURIES ASSOCIATED WITH THIS EVENT. LOT NUMBER: T11118, MANUFACTURED: (B)(6) 2011, EXPIRES: 11/14/2011. LOT NUMBER: T11124, MANUFACTURED: (B)(6) 2011, EXPIRES: 11/28/2011. NOTE: ALL "T" LOTS ASSOCIATED WITH THIS INCIDENT HAVE EXPIRED ANY 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 T1118

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK