BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    I-STAT TROPONIN (CTNI) CARTRIDGE

    MDR report key: 2453253 · Received January 23, 2012

    Report

    Report Number
    2245578-2012-00036
    Event Type
    Malfunction
    Date Received
    January 23, 2012
    Date of Event
    December 13, 2011
    Report Date
    January 4, 2012
    Manufacturer
    ABBOTT POINT OF CARE INC.
    Product Code
    MMI
    PMA / PMN Number
    K031739
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WV, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    ON (B)(6) 2012, ABBOTT POINT OF CARE WAS CONTACTED BY A CUSTOMER REGARDING I-STAT TROPONIN CARTRIDGES THAT YIELDED DISCREPANT RESULT OF 0.12 ON A PT. SAMPLE COLLECTION: (B)(6) 2011, 10/04 SAMPLE A COLLECTION; (B)(6) 2011 10:10 SAMPLE B COLLECTION. I-STAT: (B)(6) 2011, 11:48 <0.01 NG/ML (SAMPLE A); (B)(6) 2011 12:16 0.12 NG/ML (SAMPLE B); (B)(6) 2011 12:28 0.08 NG/ML (SAMPLE B). CENTAUR (LAB): (B)(6) 2011 12:54 <0.006 NG/ML; (B)(6) 2011 21/15 <0.006 NG/ML. BASED ON THE INFO AVAILABLE, 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 U11270

    Patients

    Seq Age Sex Outcome Treatment
    1 58 YR