BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INRATIO2 PT/INR TEST STRIPS

    MDR report key: 5626471 · Received May 3, 2016

    Report

    Report Number
    2027969-2016-00289
    Event Type
    Malfunction
    Date Received
    May 3, 2016
    Date of Event
    April 13, 2016
    Report Date
    April 13, 2016
    Manufacturer
    ALERE SAN DIEGO, INC.
    Product Code
    GJS
    PMA / PMN Number
    K110212
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    INVESTIGATION/CONCLUSION: IT IS INDICATED THAT THE PRODUCT IS NOT RETURNING FOR EVALUATION. THEREFORE, THERAPEUTIC DONOR TESTING WAS PERFORMED WITH AN IN-HOUSE MONITOR AND RETAINED STRIPS OF LOT K382781. IN-HOUSE TESTING OF STRIP LOT K382781 MEETS ACCURACY CRITERIA. NO PRODUCT DEFICIENCY WAS OBSERVED. THE MANUFACTURING RECORDS FOR THE LOT WERE REVIEWED AND THE LOT MET RELEASE SPECIFICATIONS. ALTHOUGH THE ROOT CAUSE ANALYSIS DID NOT INCLUDE RETURN TESTING, IMPROPER TECHNIQUE AND USER ISSUE WERE IDENTIFIED IN THE COMPLAINT. THESE COULD NOT BE RULED OUT AS A CAUSE OF THE UNEXPECTED RESULTS. BASED ON THE INFORMATION AVAILABLE, THERE IS NO INDICATION OF A PRODUCT DEFICIENCY AND NO CORRECTIVE ACTION IS REQUIRED.

    Description of Event or Problem · 1

    ON (B)(6) 2016, A VARIANCE BETWEEN THE INRATIO2 INR RESULTS WAS REPORTED ON A PATIENT IN (B)(6). RESULTS ARE AS FOLLOWS: DATE: (B)(6) 2016, INRATION2 INR: 3, 2.3 AND 2.0 (TESTING PERFORMED CONSECUTIVELY) THERAPEUTIC RANGE: 2.0 - 2.3. REPORTEDLY, THE MONITOR WAS NOT IN THE CORRECT MODE WHEN THE FINGER STICK WAS PERFORMED AND THE SAME FINGER/FINGERSTICK WAS USED FOR THE FIRST TWO (2) TESTS. THIS IS CONSIDERED TO BE A USER ISSUE AND AN IMPROPER TECHNIQUE WHEN PERFORMING THE INRATIO TEST. THERE WAS NO REPORTED ADVERSE PATIENT SEQUELA AND NO ADDITIONAL INFORMATION WAS ABLE TO BE PROVIDED. (NOTE: THIS MDR FILING IS DUE TO THE DEVICE BEING THE SAME OR SIMILAR AS A DEVICE AVAILABLE IN THE UNITED STATES.)

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    279598 INRATIO2 PT/INR TEST STRIPS PROTHROMBIN TIME TEST GJS ALERE SAN DIEGO, INC. 99008G1 K382781

    Patients

    Seq Age Sex Outcome Treatment
    1