BEUDAMED
    FDA Adverse Event Injury Summary report: N

    OT BASIC METER

    MDR report key: 1947213 · Received January 4, 2011

    Report

    Report Number
    2939301-2011-00149
    Event Type
    Injury
    Date Received
    January 4, 2011
    Date of Event
    December 10, 2010
    Report Date
    December 10, 2010
    Manufacturer
    LIFESCAN INC.
    Product Code
    NBW
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, 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. 510(K) # IS K023948.

    Description of Event or Problem · 1

    ON (B)(6), 2010 THE LAY USER/PATIENT'S DAUGHTER CONTACTED LIFESCAN (LFS) ALLEGING THAT THE PATIENT'S ONETOUCH BASIC ORIGINAL METER WAS NOT POWERING ON. THE COMPLAINT WAS CLASSIFIED BASED ON THE CUSTOMER CARE ADVOCATE (CCA) DOCUMENTATION. THE PATIENT'S DAUGHTER REPORTED THE ALLEGED ISSUE BEGAN ON (B)(6), 2010 AT BREAKFAST TIME. THE DAUGHTER INFORMED THE CCA THAT THE PATIENT MANAGES HER DIABETES WITH OTHER DIABETES MEDICATIONS (TYPE AND DOSE UNKNOWN) TO LOWER HER BLOOD SUGAR. THE DAUGHTER STATED THE PATIENT DENIED TAKING ANY ACTION REGARDING HER DIABETES MANAGEMENT REGIMEN. ACCORDING TO THE DAUGHTER, THE PATIENT WAS FEELING SHAKY IN THE LEGS AN HOUR AFTER THE ALLEGED ISSUE BEGAN. THE DAUGHTER HOWEVER REPORTED THE PATIENT DID NOT SEEK ANY MEDICAL TREATMENT. AT THE TIME OF TROUBLESHOOTING, THE CCA VERIFIED THE SUBJECT METER HAD BEEN USED BEFORE AND THAT THERE WAS NO MISUSED OF THE METER. THE CCA INFORMED THE PATIENT'S DAUGHTER THAT THE METER NEEDED A NEW BATTERY REPLACEMENT; HOWEVER THE DAUGHTER DID NOT HAVE A NEW BATTERY AVAILABLE. REPLACEMENT PRODUCTS WERE SENT TO THE PATIENT. THIS COMPLAINT IS BEING REPORTED BECAUSE THE DAUGHTER CLAIMS THE PATIENT WAS UNABLE TO TEST HER BLOOD GLUCOSE DUE TO THE REPORTED ISSUE AND REPORTEDLY DEVELOPED SYMPTOMS SUGGESTIVE OF SEVERE HYPOGLYCEMIA AFTER THE ALLEGED METER ISSUE BEGAN.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 61 YR Life Threatening