BEUDAMED
    FDA Adverse Event Other Summary report: N

    I-STAT PT/INR CARTRIDGE

    MDR report key: 800732 · Received December 13, 2006

    Report

    Report Number
    2245578-2006-00030
    Event Type
    Other
    Date Received
    December 13, 2006
    Date of Event
    November 14, 2006
    Report Date
    December 12, 2006
    Manufacturer
    ABBOTT POINT OF CARE INC.
    Product Code
    JJE
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MA, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    ABBOTT POINT OF CARE (APOC) BECAME AWARE OF PRELIMINARY TESTING PERFORMED BY FACILITY ON 11/14/2006 WHICH SUGGESTED INTERFERENCE BETWEEN THE I-STAT PT/INR ASSAY AND THEIR DRUG (ANTIBIOTIC) CUBICIN (DAPTOMYCIN FOR INJECTION). ON 11/16/2006, TESTING PERFORMED BY ABBOTT POINT OF CARE CONFIRMED THE FINDINGS. THE I-STAT PT/INR TEST WAS CLEARED VIA A 510K ON 14 MAY 2002, PREDATING THE APPROVAL OF CUBICIN. CUBICIN WAS ORIGINALLY APPROVED IN THE US SEPTEMBER 2003. THE I-STAT PRODUCT DID NOT MALFUNCTION.

    Description of Event or Problem · 1

    ABBOTT POINT OF CARE RECENTLY BECAME AWARE OF NEW INFORMATION REGARDING THE I-STAT PT/INR ASSAY. CLINICALLY RELEVANT LEVELS OF THE ANTIBIOTIC CUBICIN (DAPTOMYCIN FOR INJECTION) CAN CAUSE A CONCENTRATION-DEPENDENT FALSE PROLONGATION OF PT AND ELEVATION OF INR WHEN USING I-STAT PT/INR CARTRIDGES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 I-STAT PT/INR CARTRIDGE IVD JJE ABBOTT POINT OF CARE INC. NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 *