BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INRATIO

    MDR report key: 2220083 · Received August 12, 2011

    Report

    Report Number
    2027969-2011-01804
    Event Type
    Malfunction
    Date Received
    August 12, 2011
    Date of Event
    July 14, 2011
    Report Date
    August 12, 2011
    Manufacturer
    ALERE SAN DIEGO, INC.
    Product Code
    GJS
    PMA / PMN Number
    K021923
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WI, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    DISCREPANT RESULTS (ACCURACY) COMPARISON OF INRATIO TEST RESULT(S) WITH LAB RESULT(S) PROVIDED BY END-USER AT TIME COMPLAINT WAS FILED. DATE: (B)(6) 2011, INRATIO: 2.7, REFERENCE: 2.15, MEAN: 2.43, CONFIDENCE LIMITS: 1.6-3.4, RESULT: PASS. REPORTED RESULTS ARE WITHIN THE CONFIDENCE LIMITS FOR PASSING ACCURACY COMPARISON. THE RESULTS ARE NOT CONSIDERED DISCREPANT WITHIN THE CONTEXT OF THE DOCUMENTED VARIABILITY FOR INR TESTING. PER TECH SERVICE REP, USER REPORTED PT ON PAINKILLER MEDICATION (TYLENOL) AT THE TIME OF TESTING. PER PRODUCT INSERT, "CERTAIN PRESCRIPTION DRUGS AND OVER-THE-COUNTER MEDICATIONS (E.G., ANTIBIOTICS, PAIN RELIEVERS) CAN AFFECT THE ACTION OF ORAL ANTICOAGULANTS." PT ALSO WAS ON LOVENOX THERAPY PRIOR TO THE TIME OF TESTING. LOVENOX IS A MEMBER OF A CLASS OF ANTITHROMBOTIC AGENTS KNOWN AS LOW-MOLECULAR-WEIGHTS HEPARINS (LMWH). PER PRODUCT USER GUIDE - LIMITATIONS, "THIS TEST SHOULD NOT BE USED FOR PTS ON HEPARIN THERAPY." CONCLUSION: CHANGES IN MEDICATION CAN AFFECT INR RESULTS. PT'S MEDICATIONS COULD NOT BE RULED OUT AS A CONTRIBUTOR TO THE UNEXPECTED RESULTS. (B)(4). DUE TO THIS LOW OCCURRENCE RATE, BELOW THE ACTION THRESHOLDS MONITORED BY QA FOR CORRECTIVE ACTION (B)(4) NO FURTHER ACTION IS REQUIRED AT THIS TIME. THIS ISSUE WILL BE SUBJECT TO TRACKING AND TRENDING. NO CORRECTIVE ACTION REQUIRED AT THIS TIME AS NO PRODUCT DEFICIENCY WAS ESTABLISHED.

    Description of Event or Problem · 1

    "CALLER ALLEGED DISCREPANT RESULTS COMPARED WITH THE LAB. RESULTS AS FOLLOWS:" DATE: (B)(6) 2011, RESULTS: 2.7, LAB: 2.14. THERAPEUTIC RANGE=2.5-3.0 INR.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 INRATIO PROTHROMBIN TIME TEST GJS ALERE SAN DIEGO, INC. 100071 253024

    Patients

    Seq Age Sex Outcome Treatment
    1