BEUDAMED
    FDA Adverse Event Injury Summary report: N

    OT ULTRA2 METER

    MDR report key: 1963117 · Received January 18, 2011

    Report

    Report Number
    2939301-2011-00535
    Event Type
    Injury
    Date Received
    January 18, 2011
    Date of Event
    January 1, 2011
    Report Date
    January 3, 2011
    Manufacturer
    LIFESCAN INC.
    Product Code
    NBW
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, 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 K053529.

    Description of Event or Problem · 1

    ON (B)(6) 2011, THE LAY USER/PATIENT CONTACTED LIFESCAN (LFS) ALLEGING THAT HIS ONETOUCH ULTRA2 METER WAS POWERING OFF DURING USE. THE FOLLOWING COMPLAINT WAS CLASSIFIED BASED ON INFORMATION OBTAINED FROM THE CUSTOMER SERVICE REPRESENTATIVE (CSR). THE PATIENT ALLEGED THAT THE ISSUE BEGAN ON (B)(6) 2011 AT 12:30PM. IN ADDITION TO ORAL MEDICATION (TYPE AND DOSE UNSPECIFIED), THE PATIENT STATED HE ALSO MANAGES HIS DIABETES WITH DIET AND/OR EXERCISE. ACCORDING TO THE CSR'S DOCUMENTATION, THE PATIENT DID NOT TAKE ANY ACTION IN RESPONSE TO THE ALLEGED POWER ISSUE AND CONSEQUENTLY, 15-20 MINUTES LATER, THE PATIENT ALLEGEDLY DEVELOPED A SYMPTOM OF SHAKING AND FELL DOWN. AT AN UNKNOWN TIME LATER THE PATIENT CLAIMED HE WENT TO THE EMERGENCY ROOM (ER). AT APPROXIMATELY 3:30PM, THE PATIENT REPORTEDLY RECEIVED FOOD AND/OR DRINK FROM A HEALTH CARE PROFESSIONAL (HCP) AS TREATMENT AND ONE HOUR LATER, THE PATIENT ALLEGEDLY OBTAINED A BLOOD GLUCOSE RESULT OF "168MG/DL" WITH THE ER/HOSPITAL'S METER. AT THE TIME OF TROUBLESHOOTING, THE CSR NOTED THAT THE SUBJECT METER'S BATTERIES WERE NOT REPLACED PER OWNER'S BOOKLET RECOMMENDATION. THE PATIENT DENIED ANY TRAUMA TO THE SUBJECT METER. THIS COMPLAINT IS BEING REPORTED DUE TO THE FOLLOWING CONCLUSION: THE PATIENT CLAIMS HE WAS UNABLE TO TEST HIS 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 ULTRA2 METER GLUCOSE MONITORING SYS/KIT NBW LIFESCAN INC. 3058263

    Patients

    Seq Age Sex Outcome Treatment
    1 55 YR Life Threatening| R