BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INRATIO

    MDR report key: 1934015 · Received December 1, 2010

    Report

    Report Number
    2027969-2010-02094
    Event Type
    Malfunction
    Date Received
    December 1, 2010
    Date of Event
    November 5, 2010
    Report Date
    December 1, 2010
    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
    FL, US
    Reporter Occupation
    OTHER

    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: 4.4, MEAN: 3.15, CONFIDENCE LIMITS: 1.9-4.6. ANALYSIS OF CUSTOMER'S DATA REVEALED THAT INRATIO AND REFERENCE TEST RESULT COMPARISON 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, PT HAS ARTHRITIS AND WAS DEHYDRATED ON THE DAY OF TESTING. PATIENT'S CURRENT HEALTH CONDITION MAY HAVE AFFECTED INR TESTING AND LED TO THE UNEXPECTED INR RESULTS. AS REVIEWED ON 12/01/2010, THIRTEEN DISCREPANT RESULT COMPLAINTS WERE REPORTED FOR LOT #235737 YIELDING A COMPLAINT RATE OF 0.022%. 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. 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 WIFE) ALLEGED DISCREPANT RESULTS COMPARED WITH THE LAB. RESULTS AS FOLLOWS: DATE: (B)(6) 2010, INRATIO: 1.9, LAB: 4.4. PATIENT'S THERAPEUTIC RANGE: 2.0-2.5 INR.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 INRATIO PROTHROMBIN TIME TEST GJS ALERE SAN DIEGO, INC. 100071 235737

    Patients

    Seq Age Sex Outcome Treatment
    1 NI