BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INRATIO

    MDR report key: 1813174 · Received August 18, 2010

    Report

    Report Number
    2027969-2010-01236
    Event Type
    Malfunction
    Date Received
    August 18, 2010
    Date of Event
    July 23, 2010
    Report Date
    August 18, 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
    CT, 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: 1.6, REFERENCE: 2.3, MEAN: 1.95, CONFIDENCE LIMITS: 1.3-2.7. ANALYSIS OF THE CUSTOMER'S DATA REVEALED THAT INRATIO AND REFERENCE TEST RESULT COMPARISON MEET ACCURACY CRITERIA. THE RESULTS ARE NOT CONSIDERED DISCREPANT WITHIN THE CONTEXT OF THE DOCUMENTED VARIABILITY FOR INR TESTING. PER COMPLAINT DESCRIPTION, PT WAS APPLYING MORE THAN ONE DROP OF BLOOD. DOUBLE DROPPING (ADDING TWO DROPS TO ONE STRIP) IS A KNOWN CAUSE FOR PRE-ANALYTICAL ERRORS IN FINGERSTICK SAMPLE COLLECTION AND COULD PRODUCE INVALID INR VALUES. AS OF 08/18/2010, FIVE DISCREPANT RESULT COMPLAINTS WERE REPORTED FOR LOT #232889 YIELDING A COMPLAINT RATE OF 0.003%. 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 IS 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 FOLLOW: DATE: (B)(6) 2010, INRATIO: 1.6, LAB: 2.3.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 INRATIO PROTHROMBIN TIME TEST GJS ALERE SAN DIEGO, INC 100071 232889

    Patients

    Seq Age Sex Outcome Treatment
    1 NI