BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INRATIO

    MDR report key: 2213826 · Received August 4, 2011

    Report

    Report Number
    2027969-2011-01733
    Event Type
    Malfunction
    Date Received
    August 4, 2011
    Date of Event
    July 7, 2011
    Report Date
    August 4, 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
    MI, US
    Reporter Occupation
    NURSE

    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: 1.7, REFERENCE: 6.0, MEAN: 3.85, CONFIDENCE LIMITS: 2.2-5.3. ANALYSIS OF CUSTOMER'S DATA REVEALED THAT INRATIO AND REFERENCE TEST RESULT COMPARISON DID NOT MEET ACCURACY CRITERIA. CUSTOMER'S RESULTS ARE CONSIDERED DISCREPANT BEYOND THE CONTEXT OF THE DOCUMENTED VARIABILITY FOR INR TESTING. NO PRODUCT IS EXPECTED TO BE RETURNED. RETAINED STRIP TESTING PERFORMED ON 07/13/2011 REVEALED THAT RESULT COMPARISONS MET ACCURACY CRITERIA. INVESTIGATION RESULTS FOR RETAINED STRIP LOT #253026. AT LEAST TWO OUT OF THREE REPLICATES ARE WITHIN THE ALLOWABLE BIAS (+ OR - 1.0) FOR ACCURACY. NO FURTHER INVESTIGATION WILL BE PURSUED AT THIS TIME. (B)(4). DUE TO THIS LOW OCCURRENCE RATE, BELOW THE ACTION THRESHOLD 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 CORRECTION 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: 1.7, LAB: 6.0. PT'S THERAPEUTIC RANGE: 2.0-3.0 INR. PT TOOK A DOSE OF COUMADIN ON THE NIGHT BEFORE INRATIO TESTING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 INRATIO PROTHROMBIN TIME TEST GJS ALERE SAN DIEGO, INC. 100139 253026

    Patients

    Seq Age Sex Outcome Treatment
    1 NI