BEUDAMED
    FDA Adverse Event Injury Summary report: N

    OT ULTRA2 METER

    MDR report key: 3022362 · Received March 27, 2013

    Report

    Report Number
    3008382007-2013-06348
    Event Type
    Injury
    Date Received
    March 27, 2013
    Date of Event
    March 13, 2013
    Report Date
    March 13, 2013
    Manufacturer
    LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL
    Product Code
    NBW
    PMA / PMN Number
    K053529
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    PATIENT

    Narratives

    Description of Event or Problem · 1

    ON (B)(6) 2013, THE LAY USER/PATIENT'S SPOUSE CONTACTED LIFESCAN (LFS) CANADA ALLEGING THAT THE PATIENT'S ONETOUCH ULTRA2 METER WOULD NOT POWER ON. THE COMPLAINT WAS CLASSIFIED BASED ON THE CUSTOMER SERVICE REPRESENTATIVE (CSR) DOCUMENTATION. THE PATIENT'S WIFE REPORTED THAT THE ALLEGED POWER ISSUE STARTED ON THE MORNING OF (B)(6) 2013. THE REPORTER INFORMED THE CSR THAT THE PATIENT MANAGES HIS DIABETES WITH ORAL MEDICATION(S). IT IS NOT KNOWN IF THE PATIENT MADE ANY ADJUSTMENTS TO HIS USUAL DIABETES MANAGEMENT REGIMEN AS A RESULT OF NOT BEING ABLE TO TEST WITH THE SUBJECT METER. THE PATIENT'S SPOUSE CLAIMED THAT AFTERNOON, AT APPROXIMATELY 3PM, THE PATIENT DEVELOPED SYMPTOMS OF "SWEATY AND WEAK" AND SHE TREATED THE PATIENT WITH CHEESE AND SUGAR. AT THE TIME OF TROUBLESHOOTING, THE CSR NOTED THAT THE SUBJECT METER'S BATTERIES HAD NOT BEEN REPLACED AS RECOMMENDED IN THE OWNER'S BOOKLET. AT THE TIME OF THE CALL, THE REPORTER SWITCHED THE BATTERIES OUT AND IT WAS NOTED THAT THE SUBJECT METER POWERED ON. REPLACEMENT PRODUCTS WERE SENT TO THE PATIENT. THE SUBJECT METER WAS REQUESTED TO BE RETURNED. THIS COMPLAINT IS BEING REPORTED BECAUSE THE PATIENT REPORTEDLY DEVELOPED SIGNS/SYMPTOMS SUGGESTIVE OF A SERIOUS INJURY AFTER THE ALLEGED POWER ISSUE STARTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    127093 OT ULTRA2 METER GLUCOSE MONITORING SYS/KIT NBW LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL 2879972

    Patients

    Seq Age Sex Outcome Treatment
    1 56 YR Life Threatening| R