BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INRATIO

    MDR report key: 2446963 · Received January 24, 2012

    Report

    Report Number
    2027969-2012-00109
    Event Type
    Malfunction
    Date Received
    January 24, 2012
    Date of Event
    January 12, 2012
    Report Date
    January 24, 2012
    Manufacturer
    ALERE SAN DIEGO, INC.
    Product Code
    GJS
    PMA / PMN Number
    K021923
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    CUSTOMER USES ALCOHOL PREP PADS AND IS NOT SURE THAT IT IS COMPLETELY DRY EACH TIME PRIOR TO PRICKING THE FINGER AND APPLYING THE SAMPLE. THIS MAY CONTRIBUTE TO UNEXPECTED INR RESULTS OR ERRORS IN TESTING. INRATIO PRECISION DATA PROVIDED BY END-USER: DATE: (B)(6) 2012. FIRST INR = >7.5; SECOND INR = 3.5. MEAN = N/A; SD = N/A; %CV = N/A. SINCE % CV IS MORE THAN 20%, THE PRECISION TEST FAILED THE CRITERIA FOR PRECISION. ADDITIONAL INVESTIGATION IS REQUIRED. RECENT TEST CONDUCTED ON LOT 254609 ON (B)(6) 2011, MET PRECISION CRITERIA. TESTS RESULTS ARE AS FOLLOWS: DONOR 106 = 2.3, 2.4, 2.3 INR; DONOR 107 = 2.3, 2.4, 2.3 INR. IN-HOUSE TEST RESULTS HAVE 2.47% AND 2.47% RESPECTIVELY FOR EACH DONOR AND ARE LESS THAN 16% CV. NO FURTHER INVESTIGATION WILL BE PURSUED AT THIS TIME. CONCLUSION: ANALYSIS OF THE CLIENT¿S DATA FROM REPEATED INRATIO TESTS REVEALED THAT TEST RESULT COMPARISON DID NOT MEET PRECISION CRITERIA. ALCOHOL CONTAMINATING FINGER STICK COULD AFFECT TEST RESULT. RECENT TEST CONDUCTED ON LOT 254609 ON (B)(6) 2011, MET PRECISION CRITERIA. RECENT TEST CONDUCTED ON LOT 254609 ON (B)(6) 2011, MET ACCURACY CRITERIA. AS REVIEWED ON (B)(6) 2011, 256 DISCREPANT RESULTS COMPLAINT WAS REPORTED FOR LOT # 254609 YIELDING A COMPLAINT RATE OF 0.168%. ACTION THRESHOLD (>0.07%) HAS BEEN REACHED. DUE TO INCREASE IN DISCREPANT COMPLAINTS WITH INRATIO STRIPS, THIS ISSUE WAS ESCALATED TO CAPA (B)(4) .

    Description of Event or Problem · 1

    ¿CALLER ALLEGED IMPRECISION WITH INRATIO METER. RESULTS AS FOLLOWS:¿ INITIAL RESULT >7.5, RETEST 3.5. PATIENT SELF-TESTER STATES THAT HE HAS BEEN RECEIVING RESULTS WITHIN HIS THERAPEUTIC RANGE AND >7.5 INTERMITTENTLY AND OFTEN HAD TO TEST MULTIPLE TIMES. THIS HAS HAPPENED FOR A FEW WEEKS - NO EXACT DATE GIVEN. CUSTOMER PROVIDED AN EXAMPLE FROM TODAY¿S TESTS. THERAPEUTIC RANGE 2.5-3.5. CUSTOMER USES ALCOHOL PREP PADS AND IS NOT SURE THAT IT IS COMPLETELY DRY EACH TIME PRIOR TO PRICKING THE FINGER AND APPLYING THE SAMPLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 INRATIO PROTHROMBIN TIME TEST GJS ALERE SAN DIEGO, INC. 100071 254609

    Patients

    Seq Age Sex Outcome Treatment
    1