BEUDAMED
    FDA Adverse Event Injury Summary report: N

    OT ULTRAMINI METER

    MDR report key: 7174329 · Received January 9, 2018

    Report

    Report Number
    3008382007-2018-00111
    Event Type
    Injury
    Date Received
    January 9, 2018
    Date of Event
    January 4, 2018
    Report Date
    January 4, 2018
    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
    MA, US
    Reporter Occupation
    OTHER CAREGIVERS

    Narratives

    Description of Event or Problem · 1

    ON (B)(6) 2018, THE PATIENT CONTACTED LIFESCAN (LFS) ALLEGING THAT HER ONETOUCH ULTRA MINI METER WAS READING INACCURATELY ERRATIC. THE COMPLAINT WAS CLASSIFIED BASED ON THE CUSTOMER CARE ADVOCATE (CCA) DOCUMENTATION. THE PATIENT REPORTED THAT THE ALLEGED PRODUCT ISSUE BEGAN ON (B)(6 2018 AROUND 12:20 PM. THE PATIENT REPORTED THAT SHE OBTAINED ALLEGED BLOOD GLUCOSE RESULTS OF ¿232, 325, 270, AND 240MG/DL¿ ON THE SUBJECT METER. PERFORMED LESS THAN 20 MINUTES APART. BASED ON STATISTICAL METHODOLOGY, THE CALCULATED DIFFERENCE OF THESE GLUCOSE RESULTS MEETS LFS¿ CRITERIA FOR PRECISION. THE PATIENT MANAGES HER DIABETES WITH ORAL MEDICATIONS (METFORMIN 1000MG TWICE DAILY) AND DENIED MAKING ANY CHANGE TO HER USUAL DIABETES MANAGEMENT ROUTINE INN RESPONSE TO THE ALLEGED PRODUCT ISSUE. THE PATIENT REPORTED THAT ON (B)(6) 2018 AROUND 12:20 PM SHE DEVELOPED THE SYMPTOMS OF SWEATY AND SHAKY FOR A SHORT MOMENT. THE PATIENT DENIED THAT SHE RECEIVED ANY TREATMENT. AT THE TIME OF TROUBLE SHOOTING, THE CCA CONFIRMED THAT THE SUBJECT METER WAS SET TO THE CORRECT UNIT OF MEASURE AND THE SAMPLE WAS TAKEN FROM AN APPROVED SAMPLE SITE. THE PATIENT¿S PRODUCTS WERE REPLACED AND REQUESTED BACK FOR EVALUATION. THIS COMPLAINT IS BEING REPORTED BECAUSE THE PATIENT REPORTEDLY DEVELOPED SIGNS AND/OR SYMPTOMS THAT MEET LFS¿ CRITERIA FOR A SERIOUS INJURY ADVERSE EVENT AFTER THE ALLEGED PRODUCT ISSUE BEGAN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    20811 OT ULTRAMINI METER GLUCOSE MONITORING SYS/KIT NBW LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL 4169912

    Patients

    Seq Age Sex Outcome Treatment
    1 54 YR Life Threatening