BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INRATIO2 PT/INR TEST STRIPS

    MDR report key: 5104742 · Received September 25, 2015

    Report

    Report Number
    2027969-2015-00703
    Event Type
    Malfunction
    Date Received
    September 25, 2015
    Date of Event
    October 21, 2014
    Report Date
    November 7, 2014
    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

    IT IS INDICATED THAT PRODUCT IS NOT RETURNING FOR EVALUATION. LOT K342375 EXPIRED IN FEBRUARY 2015. SINCE THERE WERE NO PREVIOUS REPORTED COMPLAINTS FOR THIS LOT, IN-HOUSE DONOR TESTING WAS PERFORMED USING RETAIN STRIPS WHILE THE STRIPS WERE PAST EXPIRATION. RETAIN STRIP TESTING RESULTS FAILED ACCURACY CRITERIA BUT PASSED REPEATABILITY CRITERIA. THE FAILURE OF THE ACCURACY CRITERIA MAY HAVE BEEN FROM THE USE OF EXPIRED STRIPS. THE MANUFACTURING RECORDS FOR LOT K342375 WERE REVIEWED. THE NON-CONFORMANCE ASSOCIATED WITH THIS LOT WAS NOT RELEVANT TO THE INITIAL COMPLAINT AND DOES NOT AFFECT PRODUCT PERFORMANCE. IN-HOUSE TESTING WAS PERFORMED ON LOT K336430 USING RETAIN STRIPS AND PASSED BOTH ACCURACY AND REPEATABILITY CRITERIA. THE MANUFACTURING RECORDS FOR LOT K336430 WERE REVIEWED. THE LOT MET SPECIFICATIONS AND NO NON-CONFORMANCES WERE DOCUMENTED. ROOT CAUSE COULD NOT BE DETERMINED FROM THE INFORMATION PROVIDED BY THE CUSTOMER. FURTHER INVESTIGATION INTO IN-HOUSE FAILURE ISSUES IS BEING INVESTIGATED UNDER INTERNAL (B)(4).

    Description of Event or Problem · 1

    PATIENT REPORTED UNSTABLE INR RESULTS WITH THE INRATIO TEST. RESULTS AS FOLLOWS: (B)(6) 2014: LAB INR = 2.6; (B)(6) 2014: INRATIO2 INR = 3.1. (B)(6) 2014 INRATIO INR = 1.7, 4.0 AND 2.9 (LOT: K342375); LAB INR = 6.2; INRATIO2 DEMO METER: INR 4.7 (LOT: K336430); PATIENT MONITOR = 2.4 (LOT: K342375), COAGUCHEK XS = 6.8. PATIENT'S THERAPEUTIC RANGE IS: 2-3. CASE WAS ESCALATED TO ALERE (B)(4) ON (B)(6) 2015. THIS CASE WAS IDENTIFIED DURING AN ASSESSMENT/REMEDIATION AS PART OF AN INTERNAL ASD (B)(4) RELATED TO INRATIO COMPLAINTS RECEIVED AT THE ALERE GERMANY INTAKE SITE THAT WERE NOT APPROPRIATELY DOCUMENTED IN THE ELECTRONIC CASE RECORD FOR PROCESSING AND ESCALATION FOR REGULATORY DETERMINATION. THE AVAILABLE INFORMATION IS LIMITED AND NO ADDITIONAL INFORMATION IS ABLE TO BE OBTAINED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    634905 INRATIO2 PT/INR TEST STRIPS PROTHROMBIN TIME TEST GJS ALERE SAN DIEGO, INC. 99008G1 K342375

    Patients

    Seq Age Sex Outcome Treatment
    1