BEUDAMED
    FDA Adverse Event Injury Summary report: N

    OT ULTRA METER

    MDR report key: 1982893 · Received February 9, 2011

    Report

    Report Number
    2939301-2011-01247
    Event Type
    Injury
    Date Received
    February 9, 2011
    Date of Event
    January 19, 2011
    Report Date
    January 19, 2011
    Manufacturer
    LIFESCAN INC.
    Product Code
    NBW
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WI, 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 K062195.

    Description of Event or Problem · 1

    ON (B)(6) 2011, THE LAY USER/PATIENT'S CAREGIVER CONTACTED LIFESCAN (LFS) ALLEGING THAT THE PATIENT'S ONETOUCH ULTRA METER DOES NOT TURN ON. THE FOLLOWING COMPLAINT WAS CLASSIFIED BASED ON INFORMATION OBTAINED FROM THE CUSTOMER SERVICE REPRESENTATIVE (CSR). THE REPORTER ALLEGED THAT THE ISSUE BEGAN ON (B)(6) 2011 AT 10AM. AT AN UNKNOWN TIME AFTER THE ALLEGED ISSUE OCCURRED, THE PATIENT REPORTEDLY DEVELOPED SYMPTOMS OF SHAKING AND WEAKNESS AND SUBSEQUENTLY WAS TREATED WITH FOOD AND/OR DRINK BY A HEALTH CARE PROFESSIONAL (HCP). ACCORDING TO THE CSR'S DOCUMENTATION, FIFTEEN MINUTES AFTER THE REPORTED ISSUE BEGAN THE PATIENT OBTAINED A BLOOD GLUCOSE RESULT OF "41MG/DL" WITH THE DOCTOR/CLINIC'S METER. DURING TROUBLESHOOTING, THE CSR NOTED THAT THE SUBJECT METER'S BATTERY WAS NOT REPLACED PER OWNER'S BOOKLET RECOMMENDATION. REPLACEMENT PRODUCTS WERE SENT TO THE PATIENT. THIS COMPLAINT IS BEING REPORTED DUE TO THE FOLLOWING CONCLUSION: THE REPORTER CLAIMS THE PATIENT WAS UNABLE TO TEST HER BLOOD GLUCOSE DUE TO THE ALLEGED ISSUE. THE PATIENT WAS REPORTEDLY TREATED BY AN HCP FOR SEVER HYPOGLYCEMIA AFTER THE ALLEGED ISSUE BEGAN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 OT ULTRA METER GLUCOSE MONITORING SYS/KIT NBW LIFESCAN INC. 3001586

    Patients

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