BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INRATIO

    MDR report key: 2043557 · Received March 25, 2011

    Report

    Report Number
    2027969-2011-00618
    Event Type
    Malfunction
    Date Received
    March 25, 2011
    Date of Event
    March 2, 2011
    Report Date
    March 25, 2011
    Manufacturer
    ALERE SAN DIEGO, INC
    Product Code
    GJS
    PMA / PMN Number
    021923
    Removal / Correction Number
    NI
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    DISCREPANT RESULTS (ACCURACY) COMPARISON OF INRATIO TEST WITH LAB RESULTS PROVIDED BY END-USER AT TIME COMPLAINT WAS FILED: INRATIO: 1.9, REFERENCE: 2.7, MEAN: 2.30, CONFIDENCE LIMITS: 1.4-3.1. ANALYSIS OF CUSTOMER'S DATA REVEALED THAT INRATIO AND REFERENCE TEST RESULT COMPARISON DID MEET ACCURACY CRITERIA. CUSTOMER'S RESULTS ARE NOT CONSIDERED DISCREPANT WITHIN THE CONTEXT OF THE DOCUMENTED VARIABILITY FOR INR TESTING. NO PRODUCT IS EXPECTED TO BE RETURNED. NO FURTHER INVESTIGATION REQUIRED. PER GENERAL DESCRIPTION OF COMPLAINT, PATIENT IS TAKING ANTIBIOTICS. PER PRODUCT USER GUIDE, "CERTAIN PRESCRIPTION DRUGS AND OVER-THE-COUNTER MEDICATIONS (E.G., ANTIBIOTICS, PAIN RELIEVERS) CAN AFFECT THE ACTION OF ORAL ANTICOAGULANTS. STARTING, STOPPING OR CHANGING THE DOSE CAN AFFECT THE INR VALUE." CUSTOMER WAS ALSO WIPING THE FIRST DROP OF BLOOD. PER PRODUCT USER GUIDE, IT IS ADVISED THAT THE FIRST DROP OF BLOOD BE USED. PATIENT'S MEDICATION AND IMPROPER SAMPLING TECHNIQUE COULD HAVE CONTRIBUTED TO UNEXPECTED INRATIO 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 (PATIENT'S MOTHER) ALLEGED DISCREPANT RESULTS COMPARED WITH THE LAB. RESULTS AS FOLLOWS: DATE: (B)(6) 2011, INRATIO: 1.9, LAB: 2.7. PATIENT'S THERAPEUTIC RANGE: 1.8-2.0 INR.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 INRATIO PROTHROMBIN TIME TEST GJS ALERE SAN DIEGO, INC 100071 237411

    Patients

    Seq Age Sex Outcome Treatment
    1 24 YR