BEUDAMED
    FDA Adverse Event Injury Summary report: N

    OT ULTRAMINI METER

    MDR report key: 3160974 · Received June 11, 2013

    Report

    Report Number
    3008382007-2013-16387
    Event Type
    Injury
    Date Received
    June 11, 2013
    Report Date
    May 23, 2013
    Manufacturer
    LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL
    Product Code
    NBW
    PMA / PMN Number
    K061118
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MT, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    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) 2013 THE LAY USER/ PATIENT CONTACTED LIFESCAN (LFS) ALLEGING HER ONETOUCH ULTRAMINI METER HAD BLACK MARKS ON THE DISPLAY. THE COMPLAINT WAS CLASSIFIED BASED ON THE CUSTOMER CARE ADVOCATE (CCA) DOCUMENTATION. THE PATIENT WAS UNABLE TO RECALL WHEN THE ALLEGED ISSUE FIRST STARTED. THE PATIENT REPORTED USING SELF ADJUSTING INSULIN TO MANAGE HER DIABETES. THE PATIENT REPORTED ON AN UNKNOWN DATE AND TIME SHE EXERCISED IN RESPONSE TO THE ALLEGED ISSUE. THE PATIENT REPORTED DEVELOPING SYMPTOMS OF ¿HIGH BLOOD GLUCOSE¿ 24 HOURS AFTER THE ALLEGED ISSUE OCCURRED. THE PATIENT REPORTED ON AN UNKNOWN DATE AND TIME SHE WAS TREATED IN THE EMERGENCY ROOM OR HOSPITAL FOR A BLOOD GLUCOSE OF ¿ 713 MG/DL¿ WITH INSULIN. AT THE TIME OF TROUBLESHOOTING, THE CCA WAS ABLE TO DETERMINE THIS WAS NOT THE FIRST TIME THE METER HAD BEEN USED, AND THERE WAS NO MISUSE OF THE PRODUCT. REPLACEMENT PRODUCTS WERE SENT. THIS COMPLAINT IS BEING REPORTED AS AN ADVERSE EVENT SINCE THE PATIENT CLAIMS, DUE TO THE ALLEGED ISSUE, WAS UNABLE TO TEST AND THEREFORE DEVELOPED EXTREMELY HIGH BLOOD GLUCOSE AND REQUIRED TREATMENT FROM A HEALTH CARE PROFESSIONAL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    262687 OT ULTRAMINI METER GLUCOSE MONITORING SYS/KIT NBW LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL 3357278

    Patients

    Seq Age Sex Outcome Treatment
    1 31 YR Hospitalization| L| R