BEUDAMED
    FDA Adverse Event Injury Summary report: N

    I-STAT CK-MG CARTRIDGE

    MDR report key: 2415120 · Received January 10, 2012

    Report

    Report Number
    2245578-2012-00007
    Event Type
    Injury
    Date Received
    January 10, 2012
    Date of Event
    November 29, 2011
    Report Date
    December 15, 2011
    Manufacturer
    ABBOTT POINT OF CARE INC.
    Product Code
    JLB
    PMA / PMN Number
    K051433
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AZ, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    APOC INCIDENT #(B)(4).

    Description of Event or Problem · 1

    ON (B)(4) 2011, ABBOTT POINT OF CARE WAS CONTACTED BY A CUSTOMER REGARDING TWO PTS THAT WERE SENT TO THE CATH LAB BASED ON A CK-MB RESULT. PT B I-STAT CK-MB: 19.80 ((B)(6) 2011 1043). SHEA LAB (POST CATHETERIZATION) ABBOTT ARCHITECT CTNI= 2.90 ((B)(6) 2011 1928), BECKMAN DXI CK-MB= 1570 ((B)(6) 2011 1928), ABBOTT ARCHITECT CTNI= 1.94 ((B)(6) 2011 0347), BECKMAN DXI CK-MB= 9.70 ((B)(6) 2011 0347). BECKMAN DXI CKMB (CUT OFFS)= 0.0 - 6.3 NG/DL, ABBOTT ARCHITECT CTNI (CUT OFFS): 0.01 - 0.04 = NEGATIVE, 0.05 - 0.49 = INDETERMINATE, 0.50 AND > = POSITIVE. BASED ON THE INFO AVAILABLE ABBOTT POINT OF CARE HAS DETERMINED THAT THERE IS NO EVIDENCE OF A PRODUCT DEFICIENCY. I-STAT AND LAB RESULTS APPEAR TO BE CONSISTENTLY HIGH ON BOTH PRE AND POST CATHETERIZATION. PT'S EXISTING CONDITION IS UNK.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 I-STAT CK-MG CARTRIDGE CK-MB CARTRIDGE JLB ABBOTT POINT OF CARE INC. NA D11252

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK