BEUDAMED
    FDA Adverse Event Injury Summary report: N

    OT ULTRA2 METER

    MDR report key: 2871227 · Received December 12, 2012

    Report

    Report Number
    3008382007-2012-07945
    Event Type
    Injury
    Date Received
    December 12, 2012
    Report Date
    December 4, 2012
    Manufacturer
    LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL
    Product Code
    NBW
    PMA / PMN Number
    K053529
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NM, US
    Reporter Occupation
    PATIENT

    Narratives

    Description of Event or Problem · 1

    ON (B)(6) 2012, THE LAY USER/PATIENT CONTACTED LIFESCAN (LFS) HER ONETOUCH ULTRA2 METER WAS PROMPTING AN ERROR 5 MESSAGE WHEN SHE WAS ATTEMPTING TO TEST HER BLOOD GLUCOSE. PER THE OT ULTRA2 OWNER'S BOOKLET, THE ERROR 5 MESSAGE PROMPTS WHEN THERE IS A PROBLEM WITH THE TEST STRIP OR THE CONFIRMATION WINDOW HAS NOT BEEN COMPLETELY FILLED. THE COMPLAINT WAS CLASSIFIED BASED ON THE CUSTOMER CARE ADVOCATE (CCA) DOCUMENTATION. TWO WEEKS PRIOR TO CONTACTING LFS, THE PATIENT REPORTED THE ALLEGED ISSUE FIRST OCCURRED. THE PATIENT REPORTED USING ORAL MEDICATIONS WITH DIET AND EXERCISE TO MANAGE HER DIABETES. IT IS UNKNOWN IF THE PATIENT MADE ANY CHANGES TO HER USUAL DIET, ACTIVITY LEVEL OR MEDICATIONS ON THE DAY OF THE ALLEGED ISSUE. THE PATIENT REPORTED ON (B)(6) 2012 AT 10:30AM SHE OBTAINED A READING OF "65MG/DL" ON ANOTHER UNKNOWN METER, AND TREATED HERSELF WITH GLUCOSE TABLETS. AT THE TIME OF TROUBLESHOOTING, THE CCA DETERMINED THIS WAS NOT THE FIRST TIME THE SUBJECT METER HAD BEEN USED. THE CCA ALSO NOTED THE PATIENT'S TEST STRIPS WERE IN GOOD CONDITION. THE CCA DISCOVERED THE PATIENT'S TESTING PROCESS WAS CORRECT. AND THE TEST STRIP COMPLETELY DREW IN THE SAMPLE. HOWEVER THE CCA DISCOVERED THE PATIENT WAS USING COUNTERFEIT TEST STRIPS. THIS COMPLAINT IS BEING REPORTED AS AN ADVERSE EVENT BECAUSE THE PATIENT REPORTED DUE TO THE ALLEGED ISSUE, SHE DEVELOPED SYMPTOMS SUGGESTIVE OF HYPOGLYCEMIA AND REQUIRED SELF TREATMENT. HOWEVER THERE IS NO INDICATION THE LFS PRODUCT MALFUNCTIONED SINCE THE PATIENT WAS USING THE INCORRECT TEST STRIPS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 OT ULTRA2 METER GLUCOSE MONITORING SYS/KIT NBW LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL 3374838

    Patients

    Seq Age Sex Outcome Treatment
    1