BEUDAMED
    FDA Adverse Event Injury Summary report: N

    OT ULTRAMINI METER

    MDR report key: 3826062 · Received May 22, 2014

    Report

    Report Number
    2939301-2014-12129
    Event Type
    Injury
    Date Received
    May 22, 2014
    Report Date
    May 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
    VT, US
    Reporter Occupation
    PATIENT

    Narratives

    Description of Event or Problem · 1

    ON (B)(6) 2014 THE LAY USER/PATIENT CONTACTED LIFESCAN (LFS) ALLEGING THAT THE ONETOUCH ULTRAMINI METER READ INACCURATELY HIGH COMPARED TO FEELING/NORMAL RESULT(S). THE FOLLOWING COMPLAINT WAS CLASSIFIED BASED ON INFORMATION OBTAINED FROM THE CUSTOMER SERVICE REPRESENTATIVE (CSR). THE PATIENT ALLEGED THAT THE ISSUE BEGAN ON (B)(6) 2014. AT UNSPECIFIED DATES/TIMES, THE PATIENT REPORTEDLY OBTAINED BLOOD GLUCOSE READINGS OF ¿172, 177, AND 176MG/DL¿ WITH THE SUBJECT METER. THE PATIENT DENIED TESTING HER BLOOD GLUCOSE WITH ANOTHER DEVICE AND ALSO DENIED MAKING ANY CHANGES TO HER INSULIN REGIMEN IN RESPONSE TO THE ALLEGED METER ISSUE. AT AN UNSPECIFIED DATE/TIME AFTERWARDS, THE PATIENT REPORTEDLY DEVELOPED SYMPTOMS OF SWEATING, RAPID HEART RATE, HEADACHE, AND FELT TIRED. ON (B)(6) (IN THE AFTERNOON), THE PATIENT REPORTEDLY CONSUMED FOOD AND/OR DRINK AS TREATMENT. AT THE TIME OF TROUBLESHOOTING, THE CSR VERIFIED THAT THE SUBJECT METER WAS SET TO THE CORRECT UNIT OF MEASUREMENT. REPLACEMENT PRODUCTS WERE SENT TO THE PATIENT. THIS COMPLAINT IS BEING REPORTED BECAUSE THE PATIENT REPORTEDLY SUFFERED SYMPTOMS SUGGESTIVE OF A SERIOUS INJURY AFTER THE ALLEGED PRODUCT ISSUE BEGAN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    304537 OT ULTRAMINI METER GLUCOSE MONITORING SYS/KIT NBW LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL 3592488

    Patients

    Seq Age Sex Outcome Treatment
    1 70 YR Life Threatening| R