BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    I-STAT TROPONIN (CTNI) CARTRIDGE

    MDR report key: 2462076 · Received February 14, 2012

    Report

    Report Number
    2245578-2012-00051
    Event Type
    Malfunction
    Date Received
    February 14, 2012
    Date of Event
    January 30, 2012
    Report Date
    January 30, 2012
    Manufacturer
    ABBOTT POINT OF CARE
    Product Code
    MMI
    PMA / PMN Number
    K031739
    Removal / Correction Number
    APOC2012-0001
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    DETAILS WILL BE PROVIDED WITH THE ACTION THAT WILL BE CONDUCTED IN COOPERATION WITH THE U.S. FOOD AND DRUG ADMINISTRATION. PRODUCT #: 06F15-04, LOT #: ALL. PRODUCT: 03P90-25, LOT#: ALL. PRODUCT #: 600-9009-25, LOT#: ALL/ BRAND NAME: I-STAT BNP CARTRIDGE. COMMON DEVICE NAME: BNP CARTRIDGE. PRODUCT#: 06F30-01, LOT#: ALL, 510(K): K031739. PRODUCT#: 06F30-02, LOT#: ALL. PRODUCT#: 03P93-25, LOT#: ALL. PRODUCT#: 600-9010-25, LOT#: ALL. BRAND NAME: I-STAT CK-MG CARTRIDGE. COMMON DEVICE NAME: CK-MB CARTRIDGE. PRODUCT#: 06F25-01, LOT#: ALL, 510(K): K051433. PRODUCT#: 06F25-02, LOT#: ALL. PRODUCT#: 03P92-25, LOT#: ALL.

    Description of Event or Problem · 1

    A REMEDIAL ACTION HAS BEEN INITIATED TO PROVIDE RECOMMENDATIONS TO THE CUSTOMER FOR PRODUCT IN THE FIELD. THROUGH A COMBINATION OF INTERNAL STUDIES AND CUSTOMER REPORTS, ABBOTT POINT OF CARE INC. (APOC) HAS DETERMINED THAT THE FREQUENCY OF SUPPRESSED RESULTS FOR I-STAT CTNI, BNP, AND CK-MB ARE AFFECTED BY ATMOSPHERIC PRESSURE. SUPPRESSED RESULT RATES MAY INCREASE WITH HIGH ELEVATIONS (DECREASED BAROMETRIC PRESSURE) AND MAY BECOME PERSISTENT IF TESTING IS PERFORMED AT MORE THAN 7500 FEET ABOVE SEA LEVEL. THE PRESSURE EFFECTS THAT LEAD TO THE INCREASED SUPPRESSED RESULT RATE DO NOT AFFECT THE ANALYTICAL RESULTS OF THE ASSAY WHEN GENERATED. THIS ACTION IS BEING CONDUCTED IN COOPERATION WITH THE U.S. FOOD AND DRUG ADMINISTRATION AND (B)(6).

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 NA