BEUDAMED
    FDA Adverse Event Injury Summary report: N

    OT ULTRA METER

    MDR report key: 2803054 · Received October 24, 2012

    Report

    Report Number
    2939301-2012-12286
    Event Type
    Injury
    Date Received
    October 24, 2012
    Report Date
    October 10, 2012
    Manufacturer
    LIFESCAN INC.
    Product Code
    NBW
    PMA / PMN Number
    K062195
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SC, 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.

    Description of Event or Problem · 1

    ON (B)(6) 2012, THE LAY USER/PATIENT CONTACTED LIFESCAN (LFS) ALLEGING HER ONETOUCH ULTRA METER WAS PROMPTING AN UNKNOWN ERROR MESSAGE WHEN SHE WAS ATTEMPTING TO TEST HER BLOOD GLUCOSE AND WAS READING INACCURATELY LOW COMPARED TO HER DOCTOR'S METER. THE MEDICAL SURVEILLANCE SPECIALIST (MSS) WAS UNABLE TO FOLLOW UP WITH THE PATIENT FOR ADDITIONAL INFORMATION. THE COMPLAINT WAS CLASSIFIED BASED ON THE CUSTOMER CARE ADVOCATE (CCA) DOCUMENTATION. ON (B)(6) 2012 AT AN UNKNOWN TIME THE PATIENT ALLEGED, THE UNKNOWN ERROR MESSAGE OCCURRED, AND SHE OBTAINED AN UNKNOWN INACCURATE LOW READING ON HER LFS METER. THE PATIENT REPORTED OBTAINING AN UNKNOWN READING ON AN UNKNOWN DATE AND TIME THAT WAS "30 POINTS HIGHER" THAN HER LFS METER READING. THE PATIENT REPORTED USING INSULIN (UNKNOWN TYPE AND DOSE) TO MANAGE HER DIABETES. THE PATIENT REPORTED MAKING NO CHANGES TO HER USUAL DIET, ACTIVITY LEVEL OR MEDICATIONS ON THE DAY OF THE ALLEGED ISSUE. HOWEVER AT AN UNKNOWN DATE AND TIME, THE PATIENT DEVELOPED SYMPTOMS OF "KETONES AND VOMITING" WHICH SHE ASSOCIATED WITH HIGH BLOOD GLUCOSE. THE PATIENT WAS REPORTEDLY HOSPITALIZED ON AN UNKNOWN DATE AND TIME AND WAS TREATED BY A HEALTHCARE PROFESSIONAL WITH "INSULIN DRIP AND FLUIDS." AT THE TIME OF TROUBLESHOOTING, THE CCA WAS UNABLE TO ASSIST THE PATIENT WITH THE ALLEGED ISSUES DUE TO THE PATIENT'S IMPAIRED VISION. REPLACEMENT PRODUCTS WERE SENT TO THE PATIENT. THIS COMPLAINT IS BEING REPORTED AS AN ADVERSE EVENT BECAUSE, THE PATIENT CLAIMS DUE TO THE ALLEGED ISSUES, THE PATIENT DEVELOPED SYMPTOMS SUGGESTIVE OF HYPERGLYCEMIA AND REQUIRED TREATMENT FROM AN HCP TO PREVENT FURTHER INJURY.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 51 YR Hospitalization| L| R