BEUDAMED
    FDA Adverse Event Injury Summary report: N

    OT ULTRA METER

    MDR report key: 2018351 · Received March 14, 2011

    Report

    Report Number
    2939301-2011-02187
    Event Type
    Injury
    Date Received
    March 14, 2011
    Report Date
    March 11, 2011
    Manufacturer
    LIFESCAN INC.
    Product Code
    NBW
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GR
    Reporter Occupation
    PATIENT

    Narratives

    Additional Manufacturer Narrative · 1

    THE 510 (K) # IS K00110. 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

    THE LAY REPORTER/ DAUGHTER CONTACTED LFS (B)(4) ON (B)(6) 2011 ALLEGING A BATTERY INDICATOR ON THE PATIENT'S ONE TOUCH ULTRA METER. THE REPORTER MENTIONED THAT THE BATTERY WAS RECENTLY REPLACED WITH A NEW BATTERY. CUSTOMER CARE ADVOCATE (CCA) SPOKE TO THE PATIENT WHO MENTIONED THAT SHE WAS UNABLE TO TEST ON THE METER SINCE THE MIDDLE OF (B)(6) 2010 AND HAS BEEN USING A FRIEND'S METER SINCE THEN TO TEST HER BLOOD GLUCOSE. SHE MENTIONED THAT DUE TO THE ALLEGED ISSUE, SHE HAD EXPERIENCED HYPOGLYCEMIC SYMPTOMS WHERE HER BODY STARTED SHAKING AND SWEATING AND FELT UNCOMFORTABLE. THE PATIENT SELF-TREATED HERSELF WITH HONEY AND THEN USED A FRIEND'S METER TO TEST HER BLOOD GLUCOSE AND HER READINGS WERE GRADUALLY INCREASING. THE PATIENT FIRST OBTAINED A 55 MG/DL AFTER TREATING HERSELF WITH HONEY AND ONCE SHE STARTED FEELING BETTER HER READINGS WERE 98-99 MG/DL. WHILE TROUBLESHOOTING ISSUE PERSISTED WITH THE BATTERY INDICATOR AND THE ALLEGED ISSUE WAS NOT RESOLVED. THE PRODUCT WAS REPLACED. THE COMPLAINT IS BEING REPORTED SINCE THE PATIENT ALLEGED THAT DUE TO THE ALLEGED BATTERY INDICATOR ON THE METER, THE PATIENT WAS UNABLE TO TEST HER BLOOD GLUCOSE, DEVELOPED SYMPTOMS AND LATER HAD TO SELF-TREAT WITH FOOD.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 OT ULTRA METER GLUCOSE MONITORING SYS/KIT NBW LIFESCAN INC. 3027048

    Patients

    Seq Age Sex Outcome Treatment
    1 66 YR Life Threatening| R