BEUDAMED
    FDA Adverse Event Injury Summary report: N

    OT ULTRA2 METER

    MDR report key: 3253256 · Received July 29, 2013

    Report

    Report Number
    3008382007-2013-21370
    Event Type
    Injury
    Date Received
    July 29, 2013
    Date of Event
    July 8, 2013
    Report Date
    July 8, 2013
    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
    NY, US
    Reporter Occupation
    PATIENT

    Narratives

    Additional Manufacturer Narrative · 1

    THE LAY USER/PATIENT¿S PRODUCT HAS BEEN RETURNED AND EVALUATED BY LIFESCAN PRODUCT ANALYSIS ON (B)(6) 2013 WITH THE FOLLOWING FINDINGS: THE METER INVOLVED IN THIS CASE HAS PASSED ALL TESTING WITH NO FAULTS FOUND; THE COMPLAINT WAS NOT CONFIRMED. IF ANY ADDITIONAL INFORMATION IS AVAILABLE, THE FDA WILL BE NOTIFIED IN A FOLLOW UP REPORT. AT THIS TIME, WE CONSIDER THIS MATTER CLOSED.

    Description of Event or Problem · 1

    ON (B)(6) 2013 THE LAY USER/PATIENT CONTACTED LIFESCAN TO REPORT THE ONE TOUCH ULTRA2 METER WAS GIVING INACCURATELY HIGH READINGS. THE SR. MEDICAL SURVEILLANCE SPECIALIST WAS ABLE TO CLASSIFY THE COMPLAINT BASED ON THE INFORMATION PROVIDED TO CUSTOMER SERVICE. ON (B)(6) 2013 AT 9:00 AM THE PATIENT OBTAINED THE BLOOD GLUCOSE READING OF 205 MG/DL ON THE REPORTED METER, AND A READING OF 159 MG/DL ON ANOTHER MANUFACTURER¿S METER WITHIN 30 MINUTES. THE PATIENT TOOK NO ACTIONS BASED ON THIS READING. FIFTEEN MINUTES AFTERWARDS, THE PATIENT EXPERIENCED THE SYMPTOMS OF SHAKING AND ¿STOMACH PROBLEMS¿. THE PATIENT DID NOT SEEK ANY MEDICAL ATTENTION OR TREATMENT. THE PATIENT MANAGES HER DIABETES WITH INSULIN TAKEN ON A SLIDING SCALE. THE METER, TEST STRIPS AND CONTROL SOLUTION WERE REPLACED. THE PATIENT RETURNED THE REPORTED METER TO LIFESCAN FOR EVALUATION. ON (B)(6) 2013 THE METER WAS EVALUATED AND PASSED TESTING WITH NO PROBLEMS FOUND. THE TEST RESULTS FELL WITHIN EXPECTED VALUES FOR METER TO METER ACCURACY COMPARISON, AND PRODUCT ANALYSIS PASSED. HOWEVER, AS THE PATIENT ALLEGEDLY SUFFERED SYMPTOMS SUGGESTING SEVERE HYPOGLYCEMIA AFTER OBTAINING AN ELEVATED BLOOD GLUCOSE READING ON THE REPORTED METER, THIS COMPLAINT IS BEING REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    353129 OT ULTRA2 METER GLUCOSE MONITORING SYS/KIT NBW LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL 3449374

    Patients

    Seq Age Sex Outcome Treatment
    1 Life Threatening