BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INRATIO

    MDR report key: 2716248 · Received August 24, 2012

    Report

    Report Number
    2027969-2012-01245
    Event Type
    Malfunction
    Date Received
    August 24, 2012
    Date of Event
    August 1, 2012
    Report Date
    August 24, 2012
    Manufacturer
    ALERGE SAN DIEGO, INC.
    Product Code
    GJS
    PMA / PMN Number
    K021923
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WA, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    REVIEW OF COMPLAINT IDENTIFIED PATIENT'S CONDITION/ CUSTOMER'S IMPROPER OPERATIONAL TECHNIQUE IN TESTS. ROOT CAUSE COULD NOT BE DETERMINED. ANALYSIS OF CLIENT'S DATA FROM INRATIO AND REFERENCE METHOD REVEALED THAT TEST RESULTS MET ACCURACY CRITERIA. ANALYSIS OF THE CLIENT'S DATA FROM REPEAT INRATIO TESTS REVEALED THAT TEST RESULTS MET PRECISION CRITERIA. NO PRODUCT IS EXPECTED TO BE RETURNED. IN-HOUSE THERAPEUTIC SAMPLE TESTING WITH RETAIN STRIPS MET ACCURACY AND PRECISION CRITERIA. AS REVIEWED, 10 DISCREPANT RESULT COMPLAINTS WERE REPORTED FOR LOT 284358 YIELDING A COMPLAINT RATE OF 0.026%. DUE TO THIS LOW OCCURRENCE RATE, BELOW THE TOTAL COMPLAINT ACTION THRESHOLD OF 0.07%, THIS ISSUE WILL CONTINUE TO BE TRACKED AND TRENDED. CORRECTIVE ACTION NOT REQUIRED AT THIS TIME.

    Description of Event or Problem · 1

    PATIENT SELF TESTER REPORTED DISCREPANT LOW READINGS. PATIENT PERFORMED 3 FINGERSTICKS ON (B)(6) 2012 ON SAME FINGER WITHIN 30 MIN - 1.3, 1.8, 1.6. THERAPEUTIC RANGE NOT PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 INRATIO PROTHROMBIN TIME TEST GJS ALERGE SAN DIEGO, INC. 100071 284358

    Patients

    Seq Age Sex Outcome Treatment
    1