BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INRATIO2 PT/INR TEST STRIPS

    MDR report key: 5766215 · Received July 1, 2016

    Report

    Report Number
    2027969-2016-00487
    Event Type
    Malfunction
    Date Received
    July 1, 2016
    Date of Event
    May 19, 2016
    Report Date
    June 7, 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

    IT IS INDICATED THAT THE PRODUCT IS NOT RETURNING FOR EVALUATION. THEREFORE, A REVIEW OF THE ENTIRE IN-HOUSE TESTING HISTORY WAS PERFORMED. IN-HOUSE TESTING ON STRIP LOT K383465 MET RELEASE CRITERIA. THE PRODUCT PERFORMED AS EXPECTED. THE MANUFACTURING RECORDS FOR THE LOT WERE REVIEWED; 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.

    Description of Event or Problem · 1

    A REPORT CONCERNING A VARIANCE BETWEEN INRATIO INR RESULTS AND LAB INR RESULTS WAS RECEIVED FROM A TRAINING CENTER IN (B)(6). THE RESULTS WERE AS FOLLOWS: (B)(6). THE THERAPEUTIC RANGE WAS NOT KNOWN. THE INRATIO RESULTS WERE TAKEN USING TWO DIFFERENT LOT NUMBERS. BOTH LOT NUMBERS WERE INVOLVED IN THE ABOVE MENTIONED RESULTS BUT THE CUSTOMER COULD NOT RECALL WHICH RESULTS WERE TAKEN WITH WHICH LOT. THIS MEDWATCH REPORT IS FOR LOT #K383465 AND MDR #2027969-2016-00486 IS FOR LOT #K379139. IT WAS STATED THAT K379139 WAS THE PATIENT'S LOT AND K383465 WAS USED IN THE PHYSICIAN'S OFFICE. THE TRAINING CENTER STATED THAT THE PATIENT'S MEDICATION WAS NOT CHANGED AND EARLIER COMPARISONS WERE ALWAYS WITHIN THE ACCEPTED RANGE. NO FURTHER DETAILS WERE PROVIDED. (NOTE: THE INRATIO2 PRODUCT 99008G1 IS NOT AVAILABLE IN THE UNITED STATES; HOWEVER, THIS MDR FILING IS DUE TO A SAME OR SIMILAR DEVICE BEING AVAILABLE IN THE UNITED STATES.)

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    419522 INRATIO2 PT/INR TEST STRIPS PROTHROMBIN TIME TEST GJS ALERE SAN DIEGO, INC. 99008G1 K383465

    Patients

    Seq Age Sex Outcome Treatment
    1