BEUDAMED
    FDA Adverse Event Injury Summary report: N

    OT ULTRA METER

    MDR report key: 2023889 · Received March 18, 2011

    Report

    Report Number
    2939301-2011-02356
    Event Type
    Injury
    Date Received
    March 18, 2011
    Report Date
    March 2, 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

    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 CONTACTED LIFESCAN (LFS) ALLEGING THAT HER ONETOUCH ULTRA METER WAS NOT POWERING ON. THE COMPLAINT WAS CLASSIFIED BASED ON THE CUSTOMER CARE ADVOCATE (CCA) DOCUMENTATION. THE PATIENT REPORTED THE ALLEGED ISSUE BEGAN AT AN UNKNOWN DATE/TIME PRIOR TO CONTACTING LFS. AS PART OF HER DIABETES REGIMEN, THE PATIENT CLAIMED SHE IS ON INSULIN (TYPE UNKNOWN). DESPITE THE ALLEGED ISSUE, THE PATIENT INDICATED SHE ADMINISTERED 6 UNITS OF INSULIN IN THE MORNING AND 15 UNITS AT NIGHT EVERY DAY. AT AN UNKNOWN DATE/TIME, THE PATIENT BECAME SHAKY AND DIZZY AFTER THE ALLEGED ISSUE BEGAN. THE PATIENT HOWEVER INDICATED SHE DID SEEK ANY MEDICAL TREATMENT. AT THE TIME OF TROUBLESHOOTING, THE CCA NOTED THE PATIENT WAS NOT A FIRST TIME USER OF THE SUBJECT METER, THERE WAS NO MISUSED OF THE METER, THE CORRECT TEST STRIPS WERE USED, AND THE BATTERY REQUIRED NO REPLACEMENT. THE ALLEGED POWER ISSUE WAS RESOLVED WITH TRAINING. REPLACEMENT PRODUCTS WERE SENT TO THE PATIENT. THIS COMPLAINT IS BEING REPORTED BECAUSE THE PATIENT CLAIMS SHE 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 ULTRA METER GLUCOSE MONITORING SYS/KIT NBW LIFESCAN INC. 3019986

    Patients

    Seq Age Sex Outcome Treatment
    1 62 YR Life Threatening