BEUDAMED
    FDA Adverse Event Injury Summary report: N

    INRATIO

    MDR report key: 1812184 · Received August 18, 2010

    Report

    Report Number
    2027969-2010-01237
    Event Type
    Injury
    Date Received
    August 18, 2010
    Date of Event
    July 26, 2010
    Report Date
    August 18, 2010
    Manufacturer
    ALERE SAN DIEGO, INC.
    Product Code
    GJS
    PMA / PMN Number
    021923
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, 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 2.3, REFERENCE 5.6, MEAN 3.95, CONFIDENCE LIMITS 2.3-5.7. ANALYSIS OF THE CUSTOMER'S DATA REVEALED THAT INRATIO AND REFERENCE TEST RESULT COMPARISON MEET ACCURACY CRITERIA. PATIENT'S CONDITION OF DIABETES COULD HAVE AFFECTED INR TESTING. AS STATED IN PRODUCT INSERT AND USER GUIDE, HEMOSENSE PRODUCTS ARE DESIGNED FOR HEMATOCRIT RANGES BETWEEN 30-55%. NO PRODUCT IS EXPECTED TO BE RETURNED. NO FURTHER INVESTIGATION REQUIRED. AS OF 08/18/2010, SIX 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 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)2010, INRATIO: 2.3, LAB: 5.6. PATIENT HAD BLOOD IN URINE AND WENT TO THE HOSPITAL RIGHT AFTER METER TEST.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 INRATIO PROTHROMBIN TIME TEST GJS ALERE SAN DIEGO, INC. 100139 232889

    Patients

    Seq Age Sex Outcome Treatment
    1 NI Hospitalization| L