BEUDAMED
    FDA Adverse Event Injury Summary report: N

    OT ULTRAMINI METER

    MDR report key: 2772109 · Received October 4, 2012

    Report

    Report Number
    2939301-2012-11433
    Event Type
    Injury
    Date Received
    October 4, 2012
    Date of Event
    September 23, 2012
    Report Date
    September 24, 2012
    Manufacturer
    LIFESCAN INC.
    Product Code
    NBW
    PMA / PMN Number
    K061118
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    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 CANADA ALLEGING THAT HER ONETOUCH ULTRAMINI METER WAS DISPLAYING A BATTERY INDICATOR. THE COMPLAINT WAS CLASSIFIED BASED ON THE CUSTOMER SERVICE REPRESENTATIVE (CSR) DOCUMENTATION, SINCE THE PATIENT WAS UNABLE TO BE REACHED BY PHONE FOR A FOLLOW-UP. THE PATIENT REPORTED THAT THE BATTERY INDICATOR APPEARED ON THE EVENING OF (B)(6) 2012. THE PATIENT INFORMED THE CSR THAT SHE MANAGES HER DIABETES WITH INSULIN (NO ADJUSTMENTS) AND DENIED TAKING ANY ACTION REGARDING HER USUAL DIABETES MANAGEMENT REGIMEN IN RESPONSE TO THE ALLEGED. THE PATIENT REPORTED THAT ON THE MORNING OF (B)(6) 2012 AT APPROXIMATELY 6:30 AM SHE DEVELOPED SYMPTOMS OF SWEATY, LIGHTHEADED AND COULD NOT SEE CLEARLY. THE PATIENT STATED SHE ASSOCIATED THESE SYMPTOMS WITH LOW BLOOD GLUCOSE AND TREATED HERSELF WITH ORANGE JUICE PER HER FEELINGS. AT THE TIME OF TROUBLESHOOTING, THE PATIENT CONFIRMED SHE HAD NOT REPLACED THE SUBJECT METER'S BATTERY AS RECOMMENDED IN THE OWNER'S BOOKLET. THE PATIENT DID NOT HAVE A NEW BATTERY AT THE TIME OF THE CALL. REPLACEMENT PRODUCTS WERE SENT TO THE PATIENT. THIS COMPLAINT IS BEING REPORTED BECAUSE THE PATIENT DEVELOPED SIGNS/SYMPTOMS SUGGESTIVE OF A SERIOUS INJURY AFTER THE ALLEGED METER ISSUE BEGAN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 OT ULTRAMINI METER GLUCOSE MONITORING SYS/KIT NBW LIFESCAN INC. 3256380

    Patients

    Seq Age Sex Outcome Treatment
    1 83 YR Life Threatening| R