BEUDAMED
    FDA Adverse Event Injury Summary report: N

    OT SELECT METER

    MDR report key: 2507910 · Received March 28, 2012

    Report

    Report Number
    2939301-2012-02954
    Event Type
    Injury
    Date Received
    March 28, 2012
    Report Date
    March 12, 2012
    Manufacturer
    LIFESCAN INC.
    Product Code
    NBW
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, 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) 2012, THE LAY USER/PATIENT CONTACTED LIFESCAN (LFS) ALLEGING SHE WAS UNABLE TO CHECK HER BLOOD GLUCOSE WITH HER ONETOUCH SELECT METER DUE TO IT NOT POWERING ON. THE COMPLAINT WAS CLASSIFIED BASED ON THE CUSTOMER CARE ADVOCATE (CCA) DOCUMENTATION. THE PATIENT CLAIMED ON AN UNKNOWN DATE AND TIME, SHE ATTEMPTED TO CHECK HER BLOOD GLUCOSE WITH THE SUBJECT DEVICE AND WAS UNABLE TO DUE TO THE ALLEGED ISSUE. THE PATIENT REPORTED THAT SHE MANAGES HER DIABETES WITH AN UNKNOWN TYPE AND DOSE OF INSULIN AND IS A SELF ADJUSTER. SHE DENIED MAKING ANY CHANGES TO HER USUAL DIABETES MANAGEMENT ROUTINE IN RESPONSE TO THE ALLEGED ISSUE. AT AN UNKNOWN TIME AFTER THE ALLEGED ISSUE BEGAN, SHE CLAIMED SHE DEVELOPED SYMPTOMS OF "SHAKING AND CONFUSION" AND DESPITE HER SYMPTOMS SHE DENIED RECEIVING ANY MEDICAL TREATMENT. AT THE TIME OF TROUBLESHOOTING, THE CCA NOTED THAT THE SUBJECT METER WAS NOT BEING USED FOR THE FIRST TIME. THE CORRECT TEST STRIPS WERE BEING USED. BASED ON THE METER'S USE AND AGE OF THE BATTERY, A REPLACEMENT BATTERY WAS NOT YET DUE. THE ALLEGED ISSUE REMAINED UNRESOLVED AFTER TROUBLESHOOTING. 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 ALLEGED METER ISSUE BEGAN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 OT SELECT METER GLUCOSE MONITORING SYS/KIT NBW LIFESCAN INC. 3208230

    Patients

    Seq Age Sex Outcome Treatment
    1 68 YR Life Threatening