BEUDAMED
    FDA Adverse Event Injury Summary report: N

    OT ULTRAMINI METER

    MDR report key: 2149829 · Received July 5, 2011

    Report

    Report Number
    2939301-2011-05558
    Event Type
    Injury
    Date Received
    July 5, 2011
    Report Date
    June 6, 2011
    Manufacturer
    LIFESCAN INC.
    Product Code
    NBW
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AZ, 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. 510K # IS K061118.

    Description of Event or Problem · 1

    ON (B)(6) 2011, THE LAY USER/PATIENT CONTACTED LIFESCAN (LFS) ALLEGING THAT HER ONETOUCH ULTRAMINI METER NO LONGER POWERED ON. THE COMPLAINT WAS CLASSIFIED BASED ON THE CUSTOMER CARE ADVOCATE (CCA) DOCUMENTATION SINCE THIS MEDICAL SURVEILLANCE SPECIALIST WAS UNABLE TO REACH THE PATIENT BY PHONE TO OBTAIN ADDITIONAL INFORMATION. THE PATIENT REPORTED THAT THE ALLEGED POWER ISSUE BEGAN APPROXIMATELY ON (B)(6) 2011, AFTER THE SUBJECT METER WAS ACCIDENTALLY SUBMERGED IN WATER. THE PATIENT INFORMED THE CCA THAT SHE MANAGES HER DIABETES WITH ORAL MEDICATIONS (GLIPIZIDE AND METFORMIN). DESPITE THE ALLEGED ISSUE, THE PATIENT DENIED MAKING ANY CHANGES TO HER USUAL DIABETES MANAGEMENT REGIMEN. ON AN UNSPECIFIED DATE/TIME, AFTER THE ALLEGED ISSUE BEGAN, THE PATIENT CLAIMED SHE DEVELOPED BLURRY VISION; HOWEVER, DENIED RECEIVING MEDICAL TREATMENT. REPLACEMENT PRODUCT WAS SENT TO THE PATIENT. THIS COMPLAINT IS BEING REPORTED BECAUSE THE PATIENT REPORTEDLY DEVELOPED SYMPTOMS INDICATIVE OF A SERIOUS INJURY AFTER THE ALLEGED METER ISSUE BEGAN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 OT ULTRAMINI METER GLUCOSE MONITORING SYS/KIT NBW LIFESCAN INC. 3085228

    Patients

    Seq Age Sex Outcome Treatment
    1 64 YR Life Threatening