BEUDAMED
    FDA Adverse Event Injury Summary report: N

    OT ULTRA2 METER

    MDR report key: 6150409 · Received December 7, 2016

    Report

    Report Number
    3008382007-2016-62841
    Event Type
    Injury
    Date Received
    December 7, 2016
    Report Date
    November 29, 2016
    Manufacturer
    LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL
    Product Code
    NBW
    UDI-DI
    00353885008372
    PMA / PMN Number
    K053529
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    PATIENT

    Narratives

    Additional Manufacturer Narrative · 1

    THE LAY USER/PATIENTS TEST STRIPS HAVE BEEN RETURNED AND EVALUATED BY LIFESCAN PRODUCT ANALYSIS WITH THE FOLLOWING FINDINGS: THE TEST STRIPS FAILED TESTING. THE REPORTED ISSUE WAS CONFIRMED. ADDITIONAL TESTS WERE PERFORMED ON THE TEST STRIP VIAL AND THE DESICCANT TO CHECK THE STRUCTURAL INTEGRITY AND FOR POSSIBLE MOISTURE ISSUE. THE STRUCTURAL INTEGRITY OF THE TEST STRIP VIAL WAS FOUND TO BE INTACT DURING A GROSS LEAK TEST. THE DESICCANT WITHIN THE SUBJECT VIAL WAS FOUND TO CONTAIN MORE MOISTURE THAN EXPECTED FROM NORMAL USE (AS PER PRODUCT LABELLING). A DEVICE HISTORY RECORD REVIEW WAS PERFORMED ON THE SUBJECT TEST STRIP LOT. THE REVIEW DID NOT IDENTIFY ANYTHING THAT COULD ADVERSELY IMPACT PRODUCT PERFORMANCE OR FUNCTION. IF LIFESCAN OBTAINS ADDITIONAL INFORMATION REGARDING THIS COMPLAINT, A FOLLOW UP REPORT WILL BE SUBMITTED. AT THIS TIME, LIFESCAN CONSIDERS THIS MATTER CLOSED.

    Additional Manufacturer Narrative · 1

    THE LAY USER/PATIENT¿S METER AND TEST STRIPS HAVE BEEN RETURNED AND EVALUATED BY LIFESCAN PRODUCT ANALYSIS WITH THE FOLLOWING FINDINGS: THE METER PASSED ALL TESTING WITH NO FAULTS FOUND. THE REPORTED ISSUE COULD NOT BE CONFIRMED. THE TEST STRIPS FAILED TESTING. THE REPORTED ISSUE WAS CONFIRMED. IF LIFESCAN OBTAINS ADDITIONAL INFORMATION REGARDING THIS COMPLAINT, A FOLLOW UP REPORT WILL BE SUBMITTED. AT THIS TIME, LIFESCAN CONSIDERS THIS MATTER CLOSED.

    Description of Event or Problem · 1

    ON (B)(6) 2016, THE LAY USER/PATIENT CONTACTED LIFESCAN (LFS) TO REPORT THAT HIS ONETOUCH ULTRA 2 METER READ INACCURATELY HIGH IN COMPARISON TO HIS FEELINGS OR NORMAL RESULTS. THE COMPLAINT WAS CLASSIFIED BASED ON CUSTOMER CARE ADVOCATE (CCA) DOCUMENTATION. THE PATIENT REPORTED THAT ON (B)(6) 2016 HE OBTAINED A RESULT OF ¿208MG/DL¿ WHICH HE FELT WAS INACCURATELY HIGH. METER TO FEELINGS COMPARISONS DO NOT MET LFS CRITERIA OF A VALID COMPARISON FOR ACCURACY. THE PATIENT MANAGES HIS DIABETES WITH METFORMIN PILLS AND LANTUS AND HUMALOG INSULIN AND STATED THAT ON (B)(6) 2016 AT 11:30PM HE INCREASED HIS DOSE OF LANTUS FROM 34 TO 56 UNITS, IN RESPONSE TO THE ALLEGEDLY HIGH RESULTS. THE PATIENT REPORTED THAT ON (B)(6) 2016, AT 05:30 ¿ 06:00AM HE DEVELOPED SYMPTOMS OF FEELING ¿WARM AND SWEATY THEN COLD AND SHAKY¿, HOWEVER DENIED RECEIVING ANY TREATMENT. DURING THE CALL THE CCA NOTED THAT THE METER WAS SET TO THE CORRECT UNIT OF MEASURE AND THE TEST STRIPS HAD NOT EXPIRED OR BEEN STORED INCORRECTLY. WHEN THE CCA WALKED THROUGH A CONTROL SOLUTION TEST WITH THE PATIENT THE RESULTS WERE NOT IN RANGE. THE PRODUCT WAS REPLACED AND REQUESTED BACK FOR EVALUATION. THIS COMPLAINT IS BEING REPORTED BECAUSE THE PATIENT REPORTEDLY DEVELOPED SIGNS AND/OR SYMPTOMS THAT MEET LFS¿ CRITERIA FOR A SERIOUS INJURY REPORTABLE ADVERSE EVENT AFTER THE ALLEGED PRODUCT ISSUE BEGAN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    801824 OT ULTRA2 METER GLUCOSE MONITORING SYS/KIT NBW LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL 3857912 00353885008372

    Patients

    Seq Age Sex Outcome Treatment
    1 71 YR Life Threatening