BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INRATIO

    MDR report key: 1826709 · Received September 1, 2010

    Report

    Report Number
    2027969-2010-01325
    Event Type
    Malfunction
    Date Received
    September 1, 2010
    Date of Event
    July 20, 2010
    Report Date
    September 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
    ME, 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: 5.0, 5.0; REFERENCE: 3.4, 3.5; MEAN: 4.20, 4.25; CONFIDENCE LIMITS: 2.4-6.1, 2.4-6.1. THE MEANS OF THE INRATIO METER AND COMPARATIVE SYSTEM INR WERE CALCULATED. BOTH INRATIO AND REFERENCE VALUES ARE WITHIN THE CONFIDENCE LIMITS FOR INR TESTING. THE RESULTS ARE NOT CONSIDERED DISCREPANT WITHIN THE CONTEXT OF THE DOCUMENTED VARIABILITY FOR INR TESTING. INR RESULTS REPORTED HAVE MET THE CRITERIA FOR ACCURACY. NO FURTHER INVESTIGATION WILL BE PURSUED. NO PRODUCT IS EXPECTED TO BE RETURNED. AS OF 09/1/2010, TEN DISCREPANT RESULT COMPLAINTS WERE REPORTED FOR LOT # 232886 YIELDING A COMPLAINT RATE OF 0.005%. 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. ONGOING TRENDING SHALL BE PERFORMED TO DETERMINE IF FURTHER ACTION IS WARRANTED. 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. RESULT AS FOLLOW: DATE: (B)(6) 2010; INRATIO: 5.0; LAB: 3.4. DATE: (B)(6) 2010; INRATIO: 5.0, LAB: 3.5.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 INRATIO PROTHROMBIN TIME TEST GJS ALERE SAN DIEGO, INC 100139 232886

    Patients

    Seq Age Sex Outcome Treatment
    1 NI