BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INRATIO PT/INR TEST STRIPS

    MDR report key: 5486863 · Received March 8, 2016

    Report

    Report Number
    2027969-2016-00142
    Event Type
    Malfunction
    Date Received
    March 8, 2016
    Date of Event
    December 29, 2015
    Report Date
    February 22, 2016
    Manufacturer
    ALERE SAN DIEGO, INC.
    Product Code
    GJS
    PMA / PMN Number
    K092987
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MO, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    IT IS INDICATED THAT THE PRODUCT IS NOT RETURNING FOR EVALUATION. THEREFORE, A REVIEW OF THE ENTIRE TESTING HISTORY FOR THE REPORTED LOT WAS PERFORMED. IN-HOUSE TESTING ON STRIP LOT 376826A MEETS RELEASE CRITERIA. THE PRODUCT PERFORMED AS EXPECTED. A REVIEW OF THE MANUFACTURING RECORDS FOR THE LOT DID NOT UNCOVER ANY NON-CONFORMANCES. THE LOT MEETS RELEASE SPECIFICATION. IT WAS REPORTED THAT THE PATIENT HAS AN UPPER RESPIRATORY INFECTION. THIS CONDITION MAY IMPACT THE PERFORMANCE OF THE ASSAY. ALTHOUGH A POTENTIAL PATIENT SAMPLE INTERFERENCE WAS IDENTIFIED IN THE COMPLAINT, A ROOT CAUSE COULD NOT BE DETERMINED FROM THE INFORMATION PROVIDED BY THE CUSTOMER. BASED ON THE INFORMATION AVAILABLE, THERE IS NO INDICATION OF A PRODUCT DEFICIENCY. NO CORRECTIVE ACTION IS REQUIRED AT THIS TIME.

    Description of Event or Problem · 1

    THE FOLLOWING WAS REPORTED VIA PHONE CALL. (B)(6). THERAPEUTIC RANGE: 2.0-3.0. TIME BETWEEN THE INRATIO TEST ON (B)(6) 2015 AND (B)(6) 2016: 10 DAYS. TIME BETWEEN THE INRATIO TEST ON (B)(6) 2016 AND LAB ON (B)(6) 2016: 13 DAYS. TIME BETWEEN THE LAB TEST ON (B)(6) 2016 AND THE INRATIO TEST ON (B)(6) "2106": 32 DAYS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    142492 INRATIO PT/INR TEST STRIPS PROTHROMBIN TIME TEST GJS ALERE SAN DIEGO, INC. 100071 376826A

    Patients

    Seq Age Sex Outcome Treatment
    1