BEUDAMED
    FDA Adverse Event Injury Summary report: N

    OT ULTRAMINI METER

    MDR report key: 4112845 · Received September 24, 2014

    Report

    Report Number
    2939301-2014-25286
    Event Type
    Injury
    Date Received
    September 24, 2014
    Report Date
    September 11, 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
    CA, US
    Reporter Occupation
    PATIENT

    Narratives

    Additional Manufacturer Narrative · 1

    TEST STRIP LOT #: INFORMATION WAS NOT PROVIDED.

    Description of Event or Problem · 1

    ON (B)(6) 2014, THE LAY USER/PATIENT CONTACTED LIFESCAN (LFS) ALLEGING THAT THE ONETOUCH ULTRAMINI METER CASING IS BROKEN. THE FOLLOWING COMPLAINT WAS CLASSIFIED BASED ON INFORMATION OBTAINED FROM THE CUSTOMER SERVICE REPRESENTATIVE (CSR). THE PATIENT DOES NOT RECALL WHEN SHE FIRST DISCOVERED THE ALLEGED ISSUE; HOWEVER, THE PATIENT INDICATED THAT IT WAS HER GRANDDAUGHTER WHO SOMEHOW BROKE THE SUBJECT METER. THE PATIENT MANAGES HER DIABETES WITH INSULIN (SELF-ADJUSTER); HOWEVER, IN RESPONSE TO THE ALLEGED METER CASING ISSUE, THE PATIENT REPORTEDLY CONSUMED A TEASPOON OF SUGAR (DATE/TIME NOT KNOWN). ACCORDING TO THE CSR¿S DOCUMENTATION, TWO DAYS AFTER DISCOVERING THE METER CASING ISSUE THE PATIENT REPORTEDLY ¿FELT LIKE SHE WAS DRUNK, EVERYTHING MOVING FASTER THAN HER, WALKING SIDEWAYS¿. ON AN UNSPECIFIED DATE/TIME, THE PATIENT REPORTEDLY WENT TO THE EMERGENCY ROOM (ER) AND DURING HER TIME IN THE ER, THE PATIENT REPORTEDLY TESTED WITH THE ER¿S METER (RESULT NOT KNOWN) AND WAS ADMINISTERED FOOD AND/OR DRINK AS TREATMENT BY A HEALTH CARE PROFESSIONAL (HCP). AT THE TIME OF TROUBLESHOOTING, THE CSR CONFIRMED THE PATIENT WAS NOT USING THE METER FOR THE FIRST TIME AND CONFIRMED THERE WAS MISUSE WITH THE LFS PRODUCT. ALTHOUGH THE REPORTER INDICATED THAT THE METER CASING ISSUE WAS A CAUSED BY HER GRANDDAUGHTER, THIS COMPLAINT IS BEING REPORTED BECAUSE THE PATIENT WAS REPORTEDLY TREATED BY AN HCP FOR SEVERE HYPOGLYCEMIA AFTER THE ALLEGED PRODUCT ISSUE WAS DISCOVERED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    596165 OT ULTRAMINI METER GLUCOSE MONITORING SYS/KIT NBW LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL

    Patients

    Seq Age Sex Outcome Treatment
    1 63 YR Life Threatening| R