BEUDAMED
    FDA Adverse Event Injury Summary report: N

    OT ULTRA METER

    MDR report key: 2123796 · Received June 14, 2011

    Report

    Report Number
    2939301-2011-04803
    Event Type
    Injury
    Date Received
    June 14, 2011
    Date of Event
    June 1, 2011
    Report Date
    June 1, 2011
    Manufacturer
    LIFESCAN INC.
    Product Code
    NBW
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    PATIENT

    Narratives

    Additional Manufacturer Narrative · 1

    THE 510 (K) # IS K001109. THE PRODUCT WAS RETURNED WITH THE FOLLOWING FINDINGS: PRODUCT ANALYSIS WAS UNABLE TO GET THE READINGS, SINCE THE PCB BOARD ON THE METER WAS CONTAMINATED.

    Description of Event or Problem · 1

    THE LAY USER / PATIENT CONTACTED LFS ON (B)(6) 2011 ALLEGING THAT HIS ONE TOUCH ULTRA METER DOES NOT POWER ON. THE PATIENT HAD NOT USED THE METER FOR A YEAR AND ONLY ON (B)(6) 2011, ATTEMPTED TO TEST AND NOTICED THAT THE METER WOULD NOT POWER ON AT 8:20AM. AT AN UNSPECIFIED TIME AFTER THE ALLEGED ISSUE BEGAN THE PATIENT FELT FAINT AND WENT AND TESTED ON THE PHYSICIAN'S METER AND OBTAINED A 54 MG/DL ON THE PHYSICIAN'S METER AND WAS TREATED WITH FOOD/DRINK. THE PATIENT DID NOT RECEIVE ANY FURTHER TREATMENT. THIS IS NOT THE FIRST TIME THE PRODUCT WAS BEING USED. THE METER DID NOT POWER ON BY PRESSING THE POWER BUTTON. THE PATIENT DID NOT HAVE ANY MORE OF THE SUBJECT TEST STRIPS. THE AGENT WAS UNABLE/UNWILLING TO VERIFY WHETHER THE BATTERIES NEEDED TO BE REPLACED AFTER SPEAKING TO THE PATIENT. THE PRODUCT WAS REPLACED. ALTHOUGH THE PATIENT HAS NOT USED THE METER IN A YEAR, THE COMPLAINT IS BEING REPORTED SINCE THE PATIENT ATTEMPTED TO TEST AND WAS UNSUCCESSFUL AND LATER DEVELOPED SYMPTOMS AND HAD TO BE TREATED WITH FOOD/DRINK BY AN HCP FOR A BLOOD GLUCOSE READING OF 54 MG/DL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 OT ULTRA METER GLUCOSE MONITORING SYS/KIT NBW LIFESCAN INC. 7A2A28

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention