BEUDAMED
    FDA Adverse Event Injury Summary report: N

    OT ULTRA2 METER

    MDR report key: 6833447 · Received August 31, 2017

    Report

    Report Number
    3008382007-2017-22370
    Event Type
    Injury
    Date Received
    August 31, 2017
    Report Date
    August 28, 2017
    Manufacturer
    LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL
    Product Code
    NBW
    UDI-DI
    00353885008372
    PMA / PMN Number
    K053529
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    PATIENT

    Narratives

    Description of Event or Problem · 1

    ON (B)(6) 2017, THE LAY-USER/PATIENT CONTACTED LIFESCAN (LFS) USA, ALLEGING THAT HER ONETOUCH ULTRA2 METER WAS READING INACCURATELY ERRATIC. THE COMPLAINT WAS CLASSIFIED BASED ON THE CUSTOMER SERVICE REPRESENTATIVE (CSR) DOCUMENTATION. THE PATIENT REPORTED THAT ON (B)(6) 2017 AT AROUND 1:30 AM SHE WOKE UP WITH SYMPTOM OF ¿SWEATING PROFUSELY.¿ THE PATIENT CLAIMED SHE TESTED HER BLOOD GLUCOSE WITH THE SUBJECT METER AN UNSPECIFIED TIME AFTER SHE BECAME SYMPTOMATIC AND REPORTEDLY OBTAINED READINGS OF ¿130, 117, 85, 117 AND 83 MG/DL¿, PERFORMED WITHIN 20 MINUTES OF EACH OTHER. BASED ON STATISTICAL METHODOLOGY, THE CALCULATED DIFFERENCE OF THESE GLUCOSE RESULTS FALLS WITHIN LIFESCAN¿S CRITERIA FOR PRECISION. THE PATIENT MANAGES HER DIABETES WITH A COMBINATION OF ORAL MEDICATION (METFORMIN) AND INSULIN (HUMALOG AND LANTUS). THE PATIENT CLAIMED SHE TREATED HERSELF AT AROUND 1:45 AM WITH 1 GLUCOSE PILL AND 4 PRUNES. THE PATIENT DENIED USING ANY OTHER DEVICE TO TEST HER BLOOD GLUCOSE. DURING TROUBLESHOOTING, THE CSR CONFIRMED THAT THE UNIT OF MEASURE WAS SET CORRECTLY ON THE SUBJECT METER. THE CSR DOCUMENTED THAT THE SAME APPROVED SAMPLE SITE WAS USED FOR TESTING. REPLACEMENT PRODUCTS WERE SENT TO THE PATIENT. THIS COMPLAINT IS BEING REPORTED BECAUSE THE PATIENT REPORTEDLY DEVELOPED A SYMPTOM SUGGESTIVE OF A SERIOUS INJURY ADVERSE EVENT WHILE USING THE PRODUCT. THE SUBJECT METER COULD NOT BE RULED OUT AS A CAUSE OR CONTRIBUTOR TO THE EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    614410 OT ULTRA2 METER GLUCOSE MONITORING SYS/KIT NBW LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL 4081078 00353885008372

    Patients

    Seq Age Sex Outcome Treatment
    1 75 YR