BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INRATIO

    MDR report key: 3172380 · Received June 5, 2013

    Report

    Report Number
    2027969-2013-00444
    Event Type
    Malfunction
    Date Received
    June 5, 2013
    Date of Event
    May 21, 2013
    Report Date
    June 4, 2013
    Manufacturer
    ALERE SAN DIEGO INC
    Product Code
    GJS
    PMA / PMN Number
    K092987
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    CUSTOMER REPORTED THE USE OF THE SAME FINGER FOR MORE THAN ONE FINGERSTICK. AFTER FIRST FINGERSTICK IS PERFORMED BLOOD BEGINS TO COAGULATE TO REPAIR FINGER. THIS COAGULATED BLOOD CAN CONTAMINATE BLOOD IN THE FINGER AND AFFECT SAMPLE MIGRATION. PER USER GUIDE IF NECESSARY, REPEAT TESTING, "USING A DIFFERENT FINGER FOR THE FINGERSTICK SAMPLE". INRATIO PRECISION DATA PROVIDED BY END-USER: DATE ON: (B)(6) 2013; 1ST INR = 7.5; 2ND INR = 2.2; MEAN = 4.85; SD = 3.75; %CV = (B)(4). SINCE %CV EXCEEDS (B)(4), INRATIO METER RESULTS DO NOT PASS THE CRITERIA FOR PRECISION. FURTHER TESTING IS REQUIRED. IN-HOUSE THERAPEUTIC DONOR TESTING PERFORMED ON REPORTED LOT 305273 ON (B)(4) 2013 YIELDED THE FOLLOWING RESULTS: (B)(4). PRECISION CRITERIA HAD BEEN MET. NO FURTHER INVESTIGATION REQUIRED. CONCLUSION: ANALYSIS OF THE CLIENT'S DATA FROM REPEAT INRATIO TESTING REVEALED THAT THE TEST RESULT COMPARISON DID NOT MEET PRECISION CRITERIA. NO PRODUCT WAS EXPECTED TO BE RETURNED SO RETAIN PRODUCTS WERE USED FOR INVESTIGATION TESTING. RETAIN STRIP TESTING RESULTS MET BOTH ACCURACY AND PRECISION CRITERIA. CUSTOMER UTILIZED THE SAME FINGER FOR MULTIPLE SAMPLE COLLECTIONS. THIS CAN CROSS CONTAMINATE THE SAMPLE AND CAN CONTRIBUTE TO TESTING ERRORS. (B)(4). 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 ALLEGED IMPRECISION WITH INRATIO METER. RESULTS AS FOLLOWS:" INITIAL INRATIO = 7.8; REPEAT INRATIO = 2.2. TIME BETWEEN TESTING: 15 MINUTES. PATIENT SELF TESTER REPEATED FINGER STICK ON SAME FINGER. THERAPEUTIC RANGE = 2.5-3.5.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    249410 INRATIO PROTHROMBIN TIME TEST GJS ALERE SAN DIEGO INC 100071 305273

    Patients

    Seq Age Sex Outcome Treatment
    1 COUMADIN| A/G PRO