BEUDAMED
    FDA Adverse Event Injury Summary report: N

    OT ULTRAMINI METER

    MDR report key: 4191736 · Received October 22, 2014

    Report

    Report Number
    2939301-2014-28334
    Event Type
    Injury
    Date Received
    October 22, 2014
    Report Date
    October 14, 2014
    Manufacturer
    LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL
    Product Code
    NBW
    PMA / PMN Number
    K061118
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UT, 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) 2014 THE LAY USER/PATIENT CONTACTED LIFESCAN ALLEGING THAT THEIR ONETOUCH ULTRAMINI METER WOULD NOT TURN ON. THE FOLLOWING COMPLAINT WAS CLASSIFIED BASED ON INFORMATION OBTAINED FROM THE CUSTOMER SERVICE REPRESENTATIVE (CSR) DOCUMENTATION. THE PATIENT COULD NOT RECALL WHEN THE PRODUCT ISSUE FIRST BEGAN. THE PATIENT MANAGES THEIR DIABETES WITH SELF-ADJUSTED INSULIN. THE PATIENT REPORTED TAKING MORE FOOD/DRINK AT 1:00 PM ON (B)(6) 2014. THE PATIENT REPORTED DEVELOPING A SYMPTOM OF ¿SHAKY¿ AFTER THE PRODUCT ISSUE BEGAN BUT COULD NOT RECALL HOW MUCH TIME HAD PASSED SINCE THE START OF THE PRODUCT ISSUE. THE PATIENT DID NOT REPORT ANY TREATMENT FOR THIS SYMPTOM. AT THE TIME OF TROUBLESHOOTING THE CSR CONFIRMED THAT THE PATIENT HAD NOT REMOVED A PROTECTIVE STICKER FROM THE BATTERY AND THE POWER ISSUE WAS RESOLVED. REPLACEMENT PRODUCTS WERE SENT TO THE PATIENT. THIS COMPLAINT IS BEING REPORTED BECAUSE THE PATIENT REPORTEDLY DEVELOPED A SYMPTOM SUGGESTIVE OF A SERIOUS INJURY AFTER THE ALLEGED PRODUCT ISSUE BEGAN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    672859 OT ULTRAMINI METER GLUCOSE MONITORING SYS/KIT NBW LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL 3567405

    Patients

    Seq Age Sex Outcome Treatment
    1 63 YR Life Threatening