BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INRATIO

    MDR report key: 2781925 · Received October 5, 2012

    Report

    Report Number
    2027969-2012-01455
    Event Type
    Malfunction
    Date Received
    October 5, 2012
    Date of Event
    September 30, 2012
    Report Date
    October 5, 2012
    Manufacturer
    ALERE SAN DIEGO, INC.
    Product Code
    GJS
    PMA / PMN Number
    K021923
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CT, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    USER WAS ON LOVENOX THERAPY AT THE TIME OF TESTING. LOVENOX IS A MEMBER OF A CLASS OF ANTITHROMBOTIC AGENTS KNOWN AS LOW-MOLECULAR-WEIGHT HEPARINS (LMWH). PER PRODUCT USER GUIDE - LIMITATIONS, "THIS TEST SHOULD NOT BE USED FOR PATIENTS ON HEPARIN THERAPY." NO FURTHER ANALYSIS OF THE REPORTED RESULTS IS APPROPRIATE GIVEN THIS OFF-LABEL USE OF THE PRODUCT. THIS MAY BE ROOT CAUSE. IN-HOUSE THERAPEUTIC DONOR TESTING HAS BEEN PERFORMED ON REPORTED LOT 284364 ON (B)(4) 2012. RESULTS AS FOLLOWS: DONOR: 1, INRATIO: 2.3,2.4,2.4, REFERENCE: 2.04, BIAS THRESHOLD: 1.04-3.04, %CV: 2.44. DONOR: 2, INRATIO: 3.4, 3.5, 3.5, REFERENCE: 3.64, BIAS THRESHOLD: 2.64-4.64, %CV: 1.67. ALL REPLICATES FOR EACH DONOR ARE WITHIN THE ACCEPTABLE BIAS FOR ACCURACY. BOTH DONORS PRODUCED %CV LESS THAN 16%. PRODUCT PERFORMED AS EXPECTED. NO FURTHER INVESTIGATION IS NECESSARY. LIMITATIONS IN PI, "THIS TEST SHOULD NOT BE USED FOR PATIENTS ON HEPARIN THERAPY." THIS CONSTITUTES OFF-LABEL USE. FURTHER ANALYSIS OF THE REPORTED RESULTS WAS DETERMINED AS NOT APPROPRIATE. NO PRODUCT WAS EXPECTED TO BE RETURNED SO RETAIN PRODUCTS WERE USED FOR INVESTIGATION TESTING. RESULTS FROM RETAIN STRIP TESTING ON IN-HOUSE METERS MET BOTH ACCURACY AND PRECISION CRITERIA. (B)(4).

    Description of Event or Problem · 1

    CALLER ALLEGED DISCREPANT RESULTS WITH THE INRATIO METER. RESULTS AS FOLLOWS: DATE: (B)(6) 2012, INRATIO INR: 3.5 AND 1.3. TIME BETWEEN TESTING WAS 2 MINUTES. THERAPEUTIC RANGE 2.0-3.0 FOR PATIENT. THERE WAS NO REPORTED ADVERSE PATIENT SEQUELA. THERE WAS NO ADDITIONAL INFORMATION PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 INRATIO PROTHROMBIN TIME TEST GJS ALERE SAN DIEGO, INC. 100071 284364

    Patients

    Seq Age Sex Outcome Treatment
    1 PERCOCET| DILAUDID| LOVENOX| COUMADIN