BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INRATIO2 PT/INR TEST STRIPS

    MDR report key: 5540270 · Received March 31, 2016

    Report

    Report Number
    2027969-2016-00205
    Event Type
    Malfunction
    Date Received
    March 31, 2016
    Report Date
    March 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
    PHARMACIST

    Narratives

    Additional Manufacturer Narrative · 1

    CORRECTIONS: DEVICE AVAILABLE FOR EVALUATION?: "YES"; DEVICE RETURNED ON 6/2/2016. DATE RECEIVED BY MFR: CHANGE DATE TO "06/08/2016". DEVICE EVALUATED BY MFR?: CORRECT TO "YES" AS EVALUATION SUMMARY IS ATTACHED. THE CUSTOMER'S TEST STRIPS ASSOCIATED WITH THE COMPLAINT WAS RETURNED FOR INVESTIGATION, HOWEVER, THE METER WAS NOT RETURNED. THE COMPLAINT WAS NOT CONFIRMED DURING IN-HOUSE TESTING AND NO PRODUCT DEFICIENCIES WERE OBSERVED. THE LOT PERFORMED AS EXPECTED. THE MANUFACTURING RECORDS FOR THE LOT WERE REVIEWED AND THERE WERE NO ISSUES RELATED TO THIS COMPLAINT. 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 IS PENDING.

    Description of Event or Problem · 1

    IT WAS REPORTED, VIA A PHARMACIST IN (B)(6), THAT THERE WAS A VARIANCE BETWEEN THE INRATIO2 INR RESULTS ON STRIP LOT# K380862 IN COMPARISON TO A DIFFERENT INRATIO2 INR STRIP LOT AND THE LABORATORY INR RESULT ON A PATIENT IN 2016. THE EXACT DATE WAS UNKNOWN. RESULTS ARE AS FOLLOWS: DATE: 2016, INRATIO2 INR STRIP LOT# K380862: 1.7 AND 1.0, INRATIO2 INR STRIP LOT UNKNOWN: 2.0, LABORATORY INR: 2.0. THE TIME BETWEEN ALL TESTING AND THE THERAPEUTIC RANGE WAS UNKNOWN. THE PHARMACIST COULD NOT RULE OUT THAT THE PATIENT USED THE SAME FINGER TWICE . THE HANDLING TECHNIQUE WAS UNKNOWN AND THE PATIENT WAS NOT WILLING TO DO ANY TROUBLESHOOTING OVER THE TELEPHONE. THERE WAS NO REPORTED ADVERSE PATIENT SEQUELA AND NO ADDITIONAL INFORMATION WAS ABLE TO BE PROVIDED. (NOTE: THIS MDR FILING IS DUE TO THE DEVICE BEING THE SAME OR SIMILAR AS A DEVICE AVAILABLE IN THE UNITED STATES.)

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    195056 INRATIO2 PT/INR TEST STRIPS PROTHROMBIN TIME TEST GJS ALERE SAN DIEGO, INC. 99008G1 K380862

    Patients

    Seq Age Sex Outcome Treatment
    1