BEUDAMED
    FDA Adverse Event Injury Summary report: N

    OT ULTRA METER

    MDR report key: 2872387 · Received December 13, 2012

    Report

    Report Number
    3008382007-2012-08090
    Event Type
    Injury
    Date Received
    December 13, 2012
    Report Date
    December 1, 2012
    Manufacturer
    LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL
    Product Code
    NBW
    PMA / PMN Number
    K002134
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NH, US
    Reporter Occupation
    PATIENT

    Narratives

    Additional Manufacturer Narrative · 1

    THE PATIENT RETURNED THE REPORTED METER TO LIFESCAN FOR EVALUATION, AND THE METER PASSED TESTING WITH NO PROBLEMS FOUND.

    Description of Event or Problem · 1

    ON (B)(6) 2012 THE LAY USER/PATIENT CONTACTED LIFESCAN TO REPORT THE ONE TOUCH ULTRA METER WAS GIVING INACCURATE READINGS. THE SR. MEDICAL SURVEILLANCE SPECIALIST WAS ABLE TO CLASSIFY THE COMPLAINT BASED ON THE INFORMATION PROVIDED TO CUSTOMER SERVICE. ON AN UNSPECIFIED DATE, THE PATIENT OBTAINED THE BLOOD GLUCOSE READING OF "GREATER THAN 600 MG/DL" ON THE REPORTED METER. THE PATIENT TOOK THE ACTION OF CONSUMING LESS FOOD AND DRINK. AFTERWARDS, THE PATIENT EXPERIENCED THE SYMPTOM OF SHAKING. TROUBLESHOOTING REVEALED THE PATIENT'S TESTING TECHNIQUE WAS CORRECT, THE METER WAS PROGRAMMED FOR THE CORRECT UNIT OF MEASURE, AND THE TEST STRIPS WERE IN GOOD CONDITION AND WITHIN OPENED EXPIRATION DATING. THE PATIENT RETURNED THE REPORTED METER TO LIFESCAN FOR EVALUATION, AND THE METER PASSED TESTING WITH NO PROBLEMS FOUND. THE METER, TEST STRIPS AND CONTROL SOLUTION WERE REPLACED. THE REPORTED METER HAS BEEN EVALUATED BY LFS AND PASSED TESTING WITH NO PROBLEMS FOUND. HOWEVER, AS THE PATIENT ALLEGEDLY SUFFERED SYMPTOMS SUGGESTING SEVERE HYPOGLYCEMIA AFTER OBTAINING AN ELEVATED READING ON THE REPORTED METER, THIS COMPLAINT IS BEING REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 OT ULTRA METER GLUCOSE MONITORING SYS/KIT NBW LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL 3348930

    Patients

    Seq Age Sex Outcome Treatment
    1 Life Threatening