BEUDAMED
    FDA Adverse Event Injury Summary report: N

    OT ULTRA2 METER

    MDR report key: 2872141 · Received December 13, 2012

    Report

    Report Number
    3008382007-2012-08086
    Event Type
    Injury
    Date Received
    December 13, 2012
    Date of Event
    November 19, 2012
    Report Date
    November 19, 2012
    Manufacturer
    LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL
    Product Code
    NBW
    PMA / PMN Number
    K053529
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NC, US
    Reporter Occupation
    PATIENT

    Narratives

    Description of Event or Problem · 1

    ON (B)(6) 2012, THE LAY USER/PATIENT CONTACTED LIFESCAN (LFS) ALLEGING THAT THE DISPLAY SCREEN ON HER ONETOUCH ULTRA2 METER WAS GETTING DARK AND WAS ALSO HAVING A BACKLIGHT ISSUE. THE FOLLOWING COMPLAINT WAS CLASSIFIED BASED ON INFORMATION OBTAINED FROM THE CUSTOMER SERVICE REPRESENTATIVE (CSR). THE PATIENT ALLEGED THAT THE ISSUES BEGAN ON (B)(6) 2012 (AT 6PM). THE PATIENT MANAGES HER DIABETES WITH INSULIN (SELF ADJUSTER). THE PATIENT DENIED TAKING ANY ACTION IN RESPONSE TO THE REPORTED METER ISSUES. ACCORDING TO THE CSR'S DOCUMENTATION, AS A RESULT OF THE ALLEGED METER ISSUES, THE PATIENT REPORTEDLY DEVELOPED SYMPTOMS OF SHAKING AND SWEATING 45 MINUTES LATER. AT AN UNSPECIFIED TIME LATER (ON (B)(6)) THE PATIENT REPORTEDLY OBTAINED A BLOOD GLUCOSE READING OF "42MG/DL" WITH ANOTHER DEVICE AND WAS ADMINISTERED A GLUCAGON INJECTION BY A HEALTH CARE PROFESSIONAL (HCP) AS TREATMENT. AT THE TIME OF TROUBLESHOOTING, THE CSR VERIFIED THE PATIENT WAS NOT USING THE SUBJECT METER FOR THE FIRST TIME AND THERE WAS NO MISUSE OF THE LFS PRODUCT. REPLACEMENT PRODUCTS WERE SENT TO THE PATIENT. THIS COMPLAINT IS BEING REPORTED BECAUSE THE PATIENT REPORTEDLY DEVELOPED SYMPTOMS SUGGESTIVE OF A SERIOUS INJURY AFTER THE ALLEGED METER ISSUES BEGAN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 OT ULTRA2 METER GLUCOSE MONITORING SYS/KIT NBW LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL 3322664

    Patients

    Seq Age Sex Outcome Treatment
    1 18 YR Life Threatening| R