BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    I-STAT TROPONIN (CTNI) CARTRIDGE

    MDR report key: 2253033 · Received August 31, 2011

    Report

    Report Number
    2245578-2011-00169
    Event Type
    Malfunction
    Date Received
    August 31, 2011
    Date of Event
    August 12, 2011
    Report Date
    August 12, 2011
    Manufacturer
    ABBOTT POINT OF CARE CANADA LTD.
    Product Code
    MMI
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, 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 POINT OF CARE WAS CONTACTED BY A CUSTOMER REGARDING I-STAT TROPONIN CARTRIDGES THAT YIELDED DISCREPANT RESULT OF 0.17 NG/ML ON A PATIENT PRESENTED IN THE ER WITH CHEST PAIN. I-STAT RESULTS (NG/ML): SAMPLE A - 0.17. SAMPLE B - 0.01 (NEW SAMPLE). SAMPLE A - 0.09 REPEAT. LAB INSTRUMENT - EXO. SAMPLE A - 0.07 NG/ML. THE SUSPECTED DISCREPANT RESULTS WERE RELEASED TO THE PHYSICIAN. BASED ON THE INFORMATION AVAILABLE AT THE TIME, THERE WERE NO INJURIES ASSOCIATED WITH THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 I-STAT TROPONIN (CTNI) CARTRIDGE CTNI CARTRIDGE MMI ABBOTT POINT OF CARE CANADA LTD. NA T11111

    Patients

    Seq Age Sex Outcome Treatment
    1 23 YR