BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INRATIO

    MDR report key: 2871982 · Received December 11, 2012

    Report

    Report Number
    2027969-2012-01687
    Event Type
    Malfunction
    Date Received
    December 11, 2012
    Date of Event
    November 28, 2012
    Report Date
    December 11, 2012
    Manufacturer
    ALER SAN DIEGO, INC.
    Product Code
    GJS
    PMA / PMN Number
    K092987
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SC, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    INVESTIGATION: INRATIO PRECISION DATA PROVIDED BY END-USER LOT: DATE (B)(6) 2012. FIRST INR = 6.2, SECOND INR = 5.6, THIRD INR = 4.8, MEAN = 5.53, SD = 0.70, %CV = (B)(4). SINCE % CV IS LESS THAN (B)(4), INRATIO METER RESULTS PASS THE CRITERIA FOR PRECISION. NO FURTHER TESTING IS REQUIRED AT THIS TIME. IN-HOUSE THERAPEUTIC DONOR TESTING HAS BEEN PERFORMED ON REPORTED LOT 282258 ON (B)(4) 2012. RESULTS AS FOLLOWS: (B)(4). NO FURTHER INVESTIGATION IS NECESSARY. CONCLUSION: ANALYSIS WAS EXPECTED TO BE RETURNED SO RETAIN PRODUCTS WERE USED FOR INVESTIGATION TESTING. RETAIN STRIP TESTING RESULTS MET ACCURACY AND PRECISION CRITERIA. ROOT CAUSE COULD NOT BE DETERMINED FROM THE INFORMATION PROVIDED BY THE CUSTOMER. (B)(4). 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": INRATIO = 6.2, 5.6, 4.8 FROM DIFFERENT FINGERS/HANDS. ALL TESTS CONDUCTED WITHIN 15 MINUTES. THERAPEUTIC RANGE = 2-3.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 INRATIO PROTHROMBIN TIME TEST GJS ALER SAN DIEGO, INC. 100071 282258

    Patients

    Seq Age Sex Outcome Treatment
    1 COUMADIN| DOXYCYCLINE