BEUDAMED
    FDA Adverse Event Injury Summary report: N

    OT SELECT METER

    MDR report key: 2336535 · Received November 15, 2011

    Report

    Report Number
    2939301-2011-11059
    Event Type
    Injury
    Date Received
    November 15, 2011
    Report Date
    November 7, 2011
    Manufacturer
    LIFESCAN INC.
    Product Code
    NBW
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, 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. THE 510(K) # IS K072543.

    Description of Event or Problem · 1

    ON (B)(6) 2011, THE PATIENT/LAY-USER CONTACTED LIFESCAN (LFS) ALLEGING THAT SHE WAS EXPERIENCING A BATTERY INDICATOR ISSUE WITH HER ONE TOUCH SELECT METER. THE COMPLAINT WAS CLASSIFIED BASED ON THE CUSTOMER CARE ADVOCATE (CCA) DOCUMENTATION. THE PATIENT REPORTED THAT THE ALLEGED ISSUE WITH THE SUBJECT METER BEGAN ON THE "MORNING" OF (B)(6) 2011. SHE STATED THAT SHE MANAGES HER DIABETES WITH INSULIN (NO ADJUSTMENTS) AND DUE TO THE ALLEGED ISSUE SHE DENIED MAKING ANY CHANGES TO HER USUAL DIABETES TREATMENT. THE PATIENT CLAIMED "APPROXIMATELY 2 DAYS" AFTER THE ALLEGED ISSUE STARTED SHE FELT "DIZZY, SHAKY, SEEING LIGHT IN EYES". SHE DENIED RECEIVING ANY FORM OF MEDICAL TREATMENT IN RESPONSE TO HER SYMPTOMS. DURING THE INITIAL CALL WITH CUSTOMER SERVICE, THE AGENT NOTED THAT THE BATTERIES WERE NOT DUE FOR REPLACEMENT AND THERE WAS NO INFORMATION OF MISUSE OF THE DEVICE. REPLACEMENT PRODUCTS WERE SENT TO THE PATIENT. THIS COMPLAINT IS BEING REPORTED BECAUSE THE PATIENT CLAIMS SHE WAS UNABLE TO TEST HER BLOOD GLUCOSE DUE TO THE REPORTED ISSUE AND REPORTEDLY DEVELOPED SYMPTOMS SUGGESTIVE OF HYPOGLYCEMIA AFTER THE REPORTED ISSUE BEGAN.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 73 YR Life Threatening