BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    I-STAT CARDIAC MARKER CONTROLS

    MDR report key: 1935715 · Received December 16, 2010

    Report

    Report Number
    2245578-2010-00162
    Event Type
    Malfunction
    Date Received
    December 16, 2010
    Date of Event
    December 2, 2010
    Report Date
    December 16, 2010
    Manufacturer
    ABBOTT POINT OF CARE
    Product Code
    JJE
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    PRODUCT NAME: I-STAT CARDIAC MARKER CONTROLS PART/LIST NUMBER: CARDIAC MARKER CONTROL LEVEL 2: 136602-06F13-02, CARDIAC MARKER CONTROL LEVEL 3: 136603-06F14-02. CARDIAC MARKER CONTROL CALIBRATION VERIFICATION (CALVER) SET: 136604-06F15-02. LOT NUMBER(S): M102082 (L2), M102083 (L3), M10208 (CALVER). DETAILS WILL BE PROVIDED WITH THE ACTION THAT WILL BE CONDUCTED IN COOPERATION WITH THE U.S. FOOD AND DRUG ADMINISTRATION. (B)(4).

    Description of Event or Problem · 1

    A REMEDIAL ACTION HAS BEEN INITIATED TO PROVIDE RECOMMENDATIONS TO THE CUSTOMER FOR PRODUCT IN THE FIELD. THE I-STAT CARDIAC MARKERS CONTROLS ARE USED TO VERIFY THE INTEGRITY OF NEWLY RECEIVED I-STAT CTNI CARTRIDGES. THE I-STAT CARDIAC MARKERS CALIBRATION VERIFICATION CONTROL SET IS USED TO VERIFY THE ACCURACY OF RESULTS OVER THE MEASUREMENT RANGE OF THE I-STAT CTNI TEST. ABBOTT POINT OF CARE (APOC) HAS DETERMINED THAT FOR THE LISTED CARDIAC MARKER CONTROLS AND CALIBRATION VERIFICATION FLUID LOTS, RESULTS MAY BE GENERATED ABOVE THE UPPER VALUE ASSIGNMENT RANGE FOR SOME VIALS. INTERNAL STUDIES HAVE DETERMINED THAT THE CAUSE OF THE ISSUE IS CO2 EMITTED BY DRY ICE WHICH PENETRATES INTO THE VIALS (HEAD SPACE) DURING THE SHIPMENT PROCESS. VENTING OF THE VIALS PRIOR TO THAWING PREVENTS THE OCCURRENCE OF HIGH RESULTS. THIS ACTION IS BEING CONDUCTED IN COOPERATION WITH THE U.S. FOOD AND DRUG ADMINISTRATION AND HEALTH (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 I-STAT CARDIAC MARKER CONTROLS CARDIAC MARKER CONTROL & CAL VER SET JJE ABBOTT POINT OF CARE M102081 (L1)

    Patients

    Seq Age Sex Outcome Treatment
    1