BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    I-STAT TROPONIN (CTNI) CARTRIDGE

    MDR report key: 2306041 · Received September 26, 2011

    Report

    Report Number
    2245578-2011-00206
    Event Type
    Malfunction
    Date Received
    September 26, 2011
    Date of Event
    June 16, 2011
    Report Date
    September 13, 2011
    Manufacturer
    ABBOTT POINT OF CARE INC.
    Product Code
    MMI
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WI, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    ON (B)(6) 2011, ABBOTT PONT OF CARE WAS CONTACTED BY A CUSTOMER REGARDING I-STAT TROPONIN CARTRIDGE THAT YIELDED A HIGH FAILURE RATE 50% ON A BOX OF 20 CARTRIDGES FOR QUALITY CHECK CODE (QCC) 123. BASED ON THE INFO AVAILABLE AT THE TIME, THERE WERE NO INJURIES ASSOCIATED WITH THIS EVENT. THE INVESTIGATION WAS COMPLETED ON (B)(6) 2011. RETAINED CARTRIDGE TEST FOR LOT# T11087 RESULTS WAS NOT ABLE TO REPRODUCE THE CUSTOMER COMPLAINT OF QCC 123 AND MET THE ACCEPTANCE CRITERIA FOR DETECTED ERRORS. HOWEVER, THE LOT DID NOT MEET THE ACCEPTANCE CRITERIA FOR THE RATE OF UNDETECTED (UDT) ERRORS. THERE IS UNSUFFICIENT EVIDENCE FROM ABBOTT POINT OF CARE CONTROLLED CARTRIDGE TO SUGGEST THAT THERE IS A DEFICIENCY RELATED TO QCC 123. INVESTIGATION TO ROOT CAUSE FOR UNDETECTED ERRORS IS ONGOING.

    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 T11087

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK