BEUDAMED
    FDA Adverse Event Injury Summary report: N

    OT ULTRA METER

    MDR report key: 2820846 · Received November 6, 2012

    Report

    Report Number
    2939301-2012-12766
    Event Type
    Injury
    Date Received
    November 6, 2012
    Report Date
    October 24, 2012
    Manufacturer
    LIFESCAN INC.
    Product Code
    NBW
    PMA / PMN Number
    K062195
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TN, US
    Reporter Occupation
    PATIENT

    Narratives

    Additional Manufacturer Narrative · 1

    LIFESCAN (LFS) HAS REQUESTED RETURN OF THE SUBJECT PRODUCT(S) FOR EVALUATION. IF THE PRODUCT(S) ARE RETURNED, LFS WILL EVALUATE IT/THEM AND INFORM FDA OF PRODUCT(S) THAT DO NOT PASS INSPECTION IN A SUPPLEMENTAL REPORT.

    Description of Event or Problem · 1

    ON (B)(6) 2012, THE LAY USER/PATIENT CONTACTED LIFESCAN (LFS) ALLEGING HER ONETOUCH ULTRA METER WAS READING INACCURATELY HIGH COMPARED TO HER FEELINGS OR NORMAL RESULTS. THE COMPLAINT WAS CLASSIFIED BASED ON THE CUSTOMER CARE ADVOCATE (CCA) DOCUMENTATION. THE PATIENT REPORTED THE ALLEGED ISSUE FIRST STARTED ONE WEEK OR MORE PRIOR TO CONTACTING LFS. THE PATIENT REPORTED TAKING A COMBINATION OF ORAL MEDICATIONS (UNKNOWN TYPE AND DOSE) WITH LANTUS INSULIN (UNKNOWN DOSE) TO MANAGE HER DIABETES. THE PATIENT REPORTED FOR THE PAST 3 DAYS SHE HAS BEEN INCREASING HER DOSE OF INSULIN BY 1-2 UNITS. ON AN UNKNOWN DATE AND TIME SHE FELT "SHAKY AND NERVOUS." THE PATIENT DENIED RECEIVING ANY TREATMENT IN RESPONSE TO HER SYMPTOMS. AT THE TIME OF TROUBLESHOOTING, THE CCA NOTED THAT THE PATIENT'S TEST STRIPS WERE IN GOOD CONDITION. HOWEVER A CONTROL SOLUTION TEST WAS NOT RUN DUE TO THE PATIENT NOT HAVING ANY CONTROL SOLUTION AT THE TIME OF THE CALL. REPLACEMENT PRODUCTS WERE SENT TO THE PATIENT. THIS COMPLAINT IS BEING REPORTED BECAUSE THE PATIENT CLAIMS DUE TO THE ALLEGED ISSUE SHE WAS UNABLE TO TEST AND THEREFORE DEVELOPED SYMPTOMS SUGGESTIVE OF HYPOGLYCEMIA.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 OT ULTRA METER GLUCOSE MONITORING SYS/KIT NBW LIFESCAN INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 76 YR Life Threatening