BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INRATIO2 PT/INR TEST STRIPS

    MDR report key: 5488153 · Received March 8, 2016

    Report

    Report Number
    2027969-2016-00149
    Event Type
    Malfunction
    Date Received
    March 8, 2016
    Date of Event
    November 27, 2015
    Report Date
    February 15, 2016
    Manufacturer
    ALERE SAN DIEGO, INC.
    Product Code
    GJS
    PMA / PMN Number
    K110212
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AS
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    CORRECTION: LOT NUMBER 362392 INCLUDED ON THE INITIAL MEDWATCH REPORT WAS INCORRECT AND SHOULD HAVE BEEN LOT K362392. CONCLUSION: IT WAS STATED THAT THE CUSTOMER WAS NOT SURE WHICH LOT NUMBER WAS USED FOR TESTING. WHEN THE MONITOR MEMORY WAS REVIEWED, IT WAS DETERMINED THAT BASED OFF THE STRIP CODE THE CUSTOMER ACTUALLY USED LOT K376474. MDR 2027969-2016-00146 WAS SUBMITTED FOR THAT LOT. ALTHOUGH AN MDR WAS SUBMITTED FOR LOT K362392, IT WAS NOT REQUIRED SINCE THE LOT WAS NOT USED FOR THE PATIENT'S TESTING.

    Additional Manufacturer Narrative · 1

    CORRECTION: 'FOREIGN' WAS NOT CHECKED AS A REPORT SOURCE ON THE INITIAL MEDWATCH REPORT. THIS SHOULD HAVE BEEN CHECKED SINCE THE CASE WAS REPORTED IN (B)(6). INVESTIGATION/CONCLUSION: THE MONITOR WAS RETURNED AND INVESTIGATED UNDER MDR 2027969-2016-00146. IT IS INDICATED THAT THE CUSTOMER'S STRIPS ARE NOT RETURNING FOR EVALUATION. THEREFORE, A REVIEW OF THE ENTIRE IN-HOUSE TESTING HISTORY OF THE LOT WAS PERFORMED. IN-HOUSE STRIP TESTING ON THE REPORTED STRIP LOT MEETS ACCURACY CRITERIA. NO PRODUCT DEFICIENCY WAS OBSERVED. THE MANUFACTURING RECORDS FOR THE LOT WERE REVIEWED AND THE LOT MET RELEASE SPECIFICATIONS. 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.

    Additional Manufacturer Narrative · 1

    INVESTIGATION PENDING.

    Description of Event or Problem · 1

    CUSTOMER ALLEGING A VARIANCE BETWEEN INRATIO RESULTS IN COMPARISON TO THE LAB INR RESULTS. THE RESULTS WERE AS FOLLOWS: (B)(6) 2015: INRATIO INR=4.3; LAB INR= 2.3, (B)(6) 2015: INRATIO INR=3.8; LAB INR= 3.1, (B)(6) 2015: INRATIO INR=5.2; LAB INR=3.4. IT WAS REPORTED THAT ALL TESTING (INRATIO VS. LAB INR) WAS PERFORMED WITHIN 30 MINUTES OF EACH OTHER. THE CUSTOMER WAS UNABLE TO CONFIRM WHICH OF TWO LOT NUMBERS WAS USED FOR THIS TESTING. THIS MDR IS BEING SUBMITTED FOR LOT # 362392. THE SECOND LOT # K376474 WILL BE SUBMITTED ON MDR #2027969-2016-00146. NO MEDICAL INTERVENTION WAS REQUIRED. PATIENT'S THERAPEUTIC RANGE: 3.0-3.5. (NOTE: THIS DEVICE IS NOT DISTRIBUTED IN THE US; HOWEVER, THIS MDR FILING IS DUE TO THE DEVICE BEING THE SAME OR SIMILAR AS A DEVICE AVAILABLE IN THE US).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    144241 INRATIO2 PT/INR TEST STRIPS PROTHROMBIN TIME TEST GJS ALERE SAN DIEGO, INC. HS99008G1 K362392

    Patients

    Seq Age Sex Outcome Treatment
    1