BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INRATIO

    MDR report key: 2214540 · Received August 3, 2011

    Report

    Report Number
    2027969-2011-01722
    Event Type
    Malfunction
    Date Received
    August 3, 2011
    Date of Event
    July 5, 2011
    Report Date
    August 3, 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
    NY, 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: 4.3, REFERENCE: 2.84, MEAN: 3.57, CONFIDENCE LIMITS: 2.0-5.0. 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 COMPLAINT ISSUE, PATIENT HAS HYPOTHYROIDISM AND IS TAKING NORCO. 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." PATIENT CURRENT MEDICATION AND HEALTH STATUS MAY LEAD TO UNEXPECTED INR RESULT OR TESTING ERROR." (B)(4). ACTION THRESHOLD OF (B)(4) WAS REACHED. STRIP LOT #243104 IN COMPLAINT HAS STRIP CODE Z45BU WITH BRICK LOT #246544, WHICH WAS SPLIT INTO TWO DIFFERENT LOTS (243104 AND 251117). (B)(4). DUE TO THIS LOW OCCURRENCE RATE, BELOW THE ACTION THRESHOLD OF (B)(4), NO FURTHER ACTION IS REQUIRED. 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, INRATIO: 4.3, LAB: 2.84. PATIENT'S THERAPEUTIC RANGE: 2.0-3.0 INR.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 INRATIO PROTHROMBIN TIME TEST GJS ALERE SAN DIEGO, INC 100071 243104

    Patients

    Seq Age Sex Outcome Treatment
    1 NI