BEUDAMED
    FDA Adverse Event Other Summary report: N

    ABBOTT AXSYM SYSTEM

    MDR report key: 800111 · Received December 29, 2006

    Report

    Report Number
    1628664-2006-00102
    Event Type
    Other
    Date Received
    December 29, 2006
    Date of Event
    December 1, 2006
    Report Date
    December 5, 2006
    Manufacturer
    ABBOTT LABORATORIES, INC.
    Product Code
    JJE
    PMA / PMN Number
    K950915
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    UNKNOWN

    Narratives

    Additional Manufacturer Narrative · 1

    THIS IS AN INITIAL REPORT. AN INVESTIGATION IS IN PROCESS. A FINAL REPORT WILL BE SUBMITTED WHEN THE INVESTIGATION IS COMPLETE.

    Description of Event or Problem · 1

    THE CUSTOMER STATES THAT AN AXSYM TROPONIN-I ADV RESULT OF 0.0 NG/ML WAS GENERATED ON A PT SAMPLE. THE MUP SOLUTION VOLUME WAS LOW, BUT NO ERROR MESSAGE WAS GENERATED. THE CUSTOMER REPLACED THE MUP SOLUTION BOTTLE, PRIMED THE MUP SOLUTION LINE SEVERAL TIMES AND RETESTED THE SAMPLE. THE SAMPLE RETESTED AT 7.51 NG/ML FOR TROPONIN-I ADV. THE PT HAD A MYOCARDIAL INFARCTION. PATIENT TREATMENT WAS DELAYED. AFTER THE RESULT OF 7.51 NG/ML WAS REPORTED, VASCULAR DILATION WAS PERFORMED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ABBOTT AXSYM SYSTEM AUTOMATED IMMUNOASSAY ANALYZER JJE ABBOTT LABORATORIES, INC. NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1 YR Other LOT 42237M201| AXSYM TROPONIN-I ADV REAGENT LIST 2J44-20,