BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INRATIO

    MDR report key: 2862161 · Received November 29, 2012

    Report

    Report Number
    2027969-2012-01650
    Event Type
    Malfunction
    Date Received
    November 29, 2012
    Date of Event
    November 9, 2012
    Report Date
    November 29, 2012
    Manufacturer
    ALERE SAN DIEGO, INC.
    Product Code
    GJS
    PMA / PMN Number
    K021923
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AR, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    INVESTIGATION PENDING.

    Description of Event or Problem · 1

    PT SAMPLE SENT TO THE LAB DUE TO TWO DIFFERENT RESULTS OBTAINED ON THE METER. NURSE STATES THAT PT DID NOT COMPLAIN OF ANY UNUSUAL BRUISING/BLEEDING, HOWEVER, SHE STATED THAT BRUISING WOULD OCCUR IF SHE BUMPED INTO SOMETHING. PT IS NEW TO FACILITY AND NEW TO TESTING ON INRATIO METER. INRATIO 6.9 AND 2.7. LAB 10.8. FIVE MINUTES BETWEEN FINGERSTICK SAMPLES AND LAB DRAW DONE SHORTLY AFTER (ALL WITHIN MINUTES).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 INRATIO PROTHROMBIN TIME TEST GJS ALERE SAN DIEGO, INC. 100139 294387

    Patients

    Seq Age Sex Outcome Treatment
    1