BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INRATIO2 PT/INR TEST STRIPS

    MDR report key: 5978864 · Received September 26, 2016

    Report

    Report Number
    2027969-2016-00633
    Event Type
    Malfunction
    Date Received
    September 26, 2016
    Date of Event
    June 6, 2016
    Report Date
    November 21, 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 PENDING.

    Additional Manufacturer Narrative · 1

    CORRECTION(S): SERIAL NUMBER CORRECTED TO "(B)(4)". DEVICE (INRATIO TEST STRIPS) WAS AVAILABLE AND EVALUATED BUT THE INRATIO MONITOR WAS NOT RETURNED FOR EVALUATION AS INDICATED IN THE INVESTIGATION RESULTS PROVIDED IN 2027969-2016-00633 FOLLOW-UP #1. THERE IS NO CHANGE TO THE INVESTIGATION.

    Additional Manufacturer Narrative · 1

    (B)(4). THE INRATIO MONITOR ASSOCIATED WITH THE COMPLAINT WAS NOT RETURNED FOR INVESTIGATION, HOWEVER, THE CUSTOMER'S INRATIO TEST STRIPS WERE RETURNED. THEREFORE, AN IN-HOUSE INRATIO MONITOR WAS USED TO TEST RETAINED AND RETURNED STRIPS OF THE REPORTED STRIP LOT. THE LOT WAS FOUND TO BE PERFORMING WITHIN EXPECTATIONS. A REVIEW OF THE MANUFACTURING BATCH RECORDS FOR THE REPORTED TEST STRIP LOT DID NOT UNCOVER ANY NON-CONFORMANCES. THE LOT MEETS RELEASE SPECIFICATIONS. A ROOT CAUSE COULD NOT BE DETERMINED FROM THE INFORMATION PROVIDED BY THE CUSTOMER.

    Description of Event or Problem · 1

    VARIANCE REPORTED BETWEEN INRATIO INR RESULTS WITH LOT K387869 AND LAB INR RESULTS. THE COMPLAINT WAS RECEIVED VIA EMAIL. THE RESULTS WERE AS FOLLOWS: ON (B)(6) 2016 - INRATIO INR=2.8 - LABORATORY INR=2.20. ON (B)(6) 2016 - INRATIO INR=2.0 - LABORATORY INR=1.47. ON (B)(6) 2016 - INRATIO INR=2.6 - LABORATORY INR=2.16. ON (B)(6) 2016 - INRATIO INR=2.4 - LABORATORY INR=1.74. ON (B)(6) THE PATIENT TOOK ANOTHER TEST ON HIS INRATIO WITH A TEST STRIP FROM LOT K392066 WHICH HE WAS NOT CONCERNED ABOUT WHEN COMPARED TO THE LABORATORY INR=1.74 THAT SAME DAY. THE REPORTED THERAPEUTIC RANGE: 2.5-3.0. NO ADVERSE EVENT REPORTED. NO CHANGES IN MEDICATION (PHENPROCOUMON) OR DIET. (NOTE: 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
    627777 INRATIO2 PT/INR TEST STRIPS PROTHROMBIN TIME TEST GJS ALERE SAN DIEGO, INC. 99007G1 K387869

    Patients

    Seq Age Sex Outcome Treatment
    1 INRATIO MONITOR SN: (B)(4)| PHENPROCOUMON