BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INRATIO

    MDR report key: 2934940 · Received January 25, 2013

    Report

    Report Number
    2027969-2013-00086
    Event Type
    Malfunction
    Date Received
    January 25, 2013
    Date of Event
    January 16, 2013
    Report Date
    January 25, 2013
    Manufacturer
    ALERE SAN DIEGO, INC.
    Product Code
    GJS
    PMA / PMN Number
    K092987
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    CASE WAS SUBMITTED TO THE MEDICAL ADVISOR FOR REVIEW. MEDICAL ADVISOR DETERMINED THAT THE INRATIO PRODUCT DID NOT CONTRIBUTE TO THE HOSPITALIZATION THAT WAS REPORTED IN THIS COMPLAINT. MEDICAL ADVISOR CATEGORIZED THIS EVENT AS MALFUNCTION. PENDING INVESTIGATION.

    Description of Event or Problem · 1

    CALLER ALLEGED DISCREPANT RESULTS WITH THE INRATIO METER COMPARED TO THE LABORATORY. SUMMARY OF REPORTED RESULTS: DATES: (B)(6) 2013, INRATIO: (2.6), LABORATORY: (3.9), DATES: WEEK PRIOR TO TESTING, LABORATORY: (16). PT WAS SENT TO THE HOSPITAL FOR INR 16 FROM THE LABORATORY WORK; PT DID NOT TEST ON THE INRATIO METER. THE PT WAS GIVEN VITAMIN K. PT HAD VITAMIN K INJECTION THE WEEK PRIOR TO TESTING. PT'S THERAPEUTIC RANGE: 2-3. CUSTOMER WAS SITTING IN HIS CAR HOLDING THE METER IN HIS HAND TO PERFORM THE TEST. CUSTOMER DID NOT USE THE FIRST DROP OF BLOOD, AND ADDED MULTIPLE DROPS OF BLOOD.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    36269 INRATIO PROTHROMBIN TIME TEST GJS ALERE SAN DIEGO, INC. 100071

    Patients

    Seq Age Sex Outcome Treatment
    1 WARFARIN| VITAMIN K INJECTION THE WEEK PRIOR TO TESTING