BEUDAMED
    FDA Adverse Event Injury Summary report: N

    OT ULTRA2 METER

    MDR report key: 3014109 · Received March 21, 2013

    Report

    Report Number
    3008382007-2013-05906
    Event Type
    Injury
    Date Received
    March 21, 2013
    Report Date
    March 9, 2013
    Manufacturer
    LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL
    Product Code
    NBW
    PMA / PMN Number
    K053529
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THE LFS PRODUCT HAS BEEN REQUESTED FOR RETURN TO LIFESCAN FOR EVALUATION. IF THE SUBJECT PRODUCT IS RETURNED, AN EVALUATION SHALL BE COMPLETED AND A SUPPLEMENTAL REPORT WILL BE FILED. NO CONCLUSIONS CAN BE MADE AT THIS TIME.

    Description of Event or Problem · 1

    ON (B)(6) 2013 THE LAY USER/PATIENT CONTACTED LIFESCAN (LFS) ALLEGING HER ONETOUCH ULTRA2 METER WAS PROMPTING AN ERROR 1 MESSAGE WHEN SHE WAS ATTEMPTING TO TEST HER BLOOD GLUCOSE. ACCORDING TO THE OT ULTRA2 OWNER'S MANUAL, AN ERROR 1 PROMPTS WHEN THERE IS A PROBLEM WITH THE METER. THE COMPLAINT WAS CLASSIFIED BASED ON THE CUSTOMER CARE ADVOCATE (CCA) DOCUMENTATION. THE PATIENT REPORTED THE ALLEGED ISSUE FIRST OCCURRED ON DURING THE WEEK PRIOR TO CONTACTING LFS. THE PATIENT REPORTED USING SELF ADJUSTING INSULIN TO MANAGE HER DIABETES. THE PATIENT REPORTED HAVING SOMETHING MORE TO EAT OR DRINK ON (B)(6) 2013 BETWEEN 8-9AM. THE PATIENT REPORTED A FEW DAYS AFTER THE ALLEGED ISSUE FIRST OCCURRED SHE DEVELOPED SYMPTOMS OF "DELIRIOUS AND SPEAKING RANDOMLY" ON (B)(6) 2013 AT AN UNKNOWN TIME. THE PATIENT REPORTED ON (B)(6) 2013 BETWEEN 8-9AM SHE WAS TREATED BY EMERGENCY MEDICAL SERVICES (EMS), HOWEVER THE TYPE OF TREATMENT WAS NOT REPORTED. AT THE TIME OF TROUBLESHOOTING, THE CCA DETERMINED THAT THIS WAS NOT THE FIRST TIME THE METER HAD BEEN USED. REPLACEMENT PRODUCTS WERE SENT TO THE PATIENT. THIS COMPLAINT IS BEING REPORTED SINCE THE PATIENT CLAIMS DUE TO THE ALLEGED ISSUE, SHE REQUIRED ASSISTANCE FROM A HEALTHCARE PROFESSIONAL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    118279 OT ULTRA2 METER GLUCOSE MONITORING SYS/KIT NBW LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL 3267626

    Patients

    Seq Age Sex Outcome Treatment
    1 76 YR Life Threatening| R