BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    I-STAT TROPONIN (CTNI) CARTRIDGE

    MDR report key: 6580747 · Received May 20, 2017

    Report

    Report Number
    2245578-2017-00021
    Event Type
    Malfunction
    Date Received
    May 20, 2017
    Date of Event
    May 3, 2017
    Report Date
    July 21, 2017
    Manufacturer
    ABBOTT POINT OF CARE
    Product Code
    MMI
    UDI-DI
    10054749001986
    PMA / PMN Number
    K031739
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OK, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). APOC LABELING WILL BE EVALUATED DURING THE INVESTIGATION AS PERTAINING TO THE EVENT.

    Additional Manufacturer Narrative · 1

    APOC INCIDENT # (B)(4). THE INVESTIGATION WAS COMPLETED ON 07/14/2017. RETAIN PRODUCT WAS TESTED AND FUNCTIONING ACCORDING TO SPECIFICATION. RETURN PRODUCT WAS NOT AVAILABLE FOR INVESTIGATION.

    Description of Event or Problem · 1

    ON (B)(6) 2017, ABBOTT POINT OF CARE (APOC) WAS CONTACTED BY A CUSTOMER REGARDING I-STAT TROPONIN CARTRIDGES THAT YIELDED A SUSPECTED DISCREPANT RESULT OF 0.32 ON A (B)(6) YEAR OLD FEMALE PATIENT PRESENTED WITH CHEST PAIN. THERE WERE NO CLINICAL DECISIONS MADE ON THE I-STAT RESULT. THE PATIENT WAS ADMITTED FOR OBSERVATION AND AN INITIAL EKG WAS NORMAL. THERE WAS NO ADDITIONAL PATIENT INFORMATION AT THE TIME OF THIS REPORT. THE CUSTOMER STATES THAT RETURN PRODUCT IS AVAILABLE FOR INVESTIGATION. DATE: METHOD : SAMPLE: SAMPLE: TESTED: RESULT: (B)(6) 2017, I-STAT, A, WB, 23:22, 0.32. (B)(6) 2017, I-STAT, A , PLASMA, 23:33, 0.01. (B)(6) 2017, I-STAT, A, PLASMA, 23:49, 0.04. (B)(6) 2017, ARCHITECT, A, PLASMA, 00:10, 0.06. (B)(6) 2017, ARCHITECT, B, WB, 00:30, 0.07. THERE ARE NO INJURIES ASSOCIATED WITH THIS EVENT. THE INVESTIGATION IS UNDERWAY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    361728 I-STAT TROPONIN (CTNI) CARTRIDGE CTNI CARTRIDGE, MMI ABBOTT POINT OF CARE NA C16335 10054749001986

    Patients

    Seq Age Sex Outcome Treatment
    1 36 YR