BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INRATIO

    MDR report key: 2022502 · Received February 15, 2011

    Report

    Report Number
    2027969-2011-00328
    Event Type
    Malfunction
    Date Received
    February 15, 2011
    Date of Event
    January 20, 2011
    Report Date
    February 15, 2011
    Manufacturer
    ALERE SAN DIEGO, INC.
    Product Code
    GJS
    PMA / PMN Number
    K021923
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    NO DATA ANALYSIS WAS PERFORMED BECAUSE PATIENT WAS ON LOVENOX. LOVENOX IS 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." PATIENT HAS HYPERCOAGULOPATHY AND WAS RECENTLY HOSPITALIZED FOR SURGERY. PATIENT'S CURRENT HEALTH AND MEDICATION MAY AFFECT COAGULATION TEST AND CONTRIBUTE TO UNEXPECTED INR OR ERRORS IN TESTING. PREVIOUS INVESTIGATION OF STRIP LOT 237433 FROM A PREVIOUS CASE MET PRECISION CRITERIA. NO FURTHER INVESTIGATION IS REQUIRED. AS OF (B)(6) 2011, 21 DISCREPANT RESULTS COMPLAINT WAS REPORTED FOR LOT # 237433 YIELDING A COMPLAINT RATE OF 0.007%. DUE TO THIS LOW OCCURRENCE RATE, BELOW THE ACTION THRESHOLDS MONITORED BY QA FOR CORRECTIVE ACTION (0.07%), NO FURTHER ACTION IS REQUIRED AT THIS TIME. NO CORRECTIVE ACTION REQUIRED AT THIS TIME AS NO PRODUCT DEFICIENCY WAS ESTABLISHED. RETAIN STRIPS: L/N 237433. COMPARATIVE SAMPLE TESTING PERFORMED ON RETURNED PRODUCT WITH RESULTS AS DETAILED BELOW. PERCENT CV FOR FIRST DONOR CALCULATED AT 9.11%. PERCENT CV FOR SECOND DONOR CALCULATED AT 5.00. SINCE % CV FOR BOTH DONORS FALLS BELOW PRECISION THRESHOLD OF 20%, NO FURTHER ACTION IS REQUIRED.

    Description of Event or Problem · 1

    CUSTOMER ALLEGES DISCREPANT RESULTS WITH METER: DATE: (B)(6) 2011, INRATIO: 1.2, RETEST INRATIO: 1.7. RETEST WAS PERFORMED WITHIN 5 MINUTES OF FIRST TEST. PATIENT IS ON A HIGHER THAN NORMAL COUMADIN DOSE AND IS CURRENTLY BRIDGING LOVENOX TO COUMADIN THERAPY. PATIENT'S TARGET THERAPEUTIC RANGE IS 2.5-3.5.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 INRATIO PROTHROMBIN TIME TEST GJS ALERE SAN DIEGO, INC. 100071 237433

    Patients

    Seq Age Sex Outcome Treatment
    1