BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    I-STAT TROPONIN (CTNI) CARTRIDGE

    MDR report key: 2314668 · Received October 6, 2011

    Report

    Report Number
    2245578-2011-00243
    Event Type
    Malfunction
    Date Received
    October 6, 2011
    Date of Event
    September 6, 2011
    Report Date
    September 23, 2011
    Manufacturer
    ABBOTT POINT OF CARE INC.
    Product Code
    MMI
    Removal / Correction Number
    APOC2011-007
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WV, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    APOC INCIDENT (B)(4). MFR REPORT #2245578-2011-00217 THROUGH 2245578-2011-00222, 2245578-2011-00228 AND 2245578-2011-00243 THROUGH 2245578-2011-00259 ARE FROM A SINGLE USER SITE. APOC PRODUCT ACTION NUMBER: (B)(4). DETAILS WILL BE PROVIDED WITH THE ACTION THAT WILL BE CONDUCTED IN COOPERATION WITH THE U.S. FOOD AND DRUG ADMINISTRATION.

    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 ON A PATIENT. I-STAT TESTING RESULTS (NG/ML): (B)(6) 2011, 16:51 INITIAL COLLECTION, (B)(6) 2011, 16:51 INITIAL TESTING WITH RESULT OF 0.01; (B)(6) 2011, 18.11 90 MINUTE COLLECTION; (B)(6) 2011, 18:15 90 MINUTE TESTING WITH RESULT OF 0.07. NO REPEAT TESTING PERFORMED ON THE I-STAT. CENTAUR LAB CTNI RESULT: (B)(6) 2011: 22:50 RESULT: 0.015; (B)(6) 2011: 10:54 RESULT: 0.019; (B)(6) 2011: UNK RESULT: 0.013. THE SUSPECTED DISCREPANT RESULTS WERE RELEASED TO A PHYSICIAN OR CAREGIVER. 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 INC. NA T11140

    Patients

    Seq Age Sex Outcome Treatment
    1 72 YR