BEUDAMED
    FDA Adverse Event Injury Summary report: N

    OT ULTRA2 METER

    MDR report key: 3203099 · Received July 2, 2013

    Report

    Report Number
    3008382007-2013-18866
    Event Type
    Injury
    Date Received
    July 2, 2013
    Date of Event
    May 4, 2013
    Report Date
    June 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
    CA, US
    Reporter Occupation
    PATIENT

    Narratives

    Description of Event or Problem · 1

    ON (B)(6) , 2013, THE LAY USER/PATIENT CONTACTED LIFESCAN (LFS) ALLEGING THAT HER ONETOUCH ULTRA2 METER WAS DISPLAYING AN ERROR 5 MESSAGE. THE MEDICAL SURVEILLANCE SPECIALIST (MSS) WAS UNABLE TO REACH THE LAY USER/PATIENT BY PHONE FOR FOLLOW-UP QUESTIONS. THE FOLLOWING COMPLAINT WAS CLASSIFIED BASED ON INFORMATION OBTAINED FROM THE CUSTOMER SERVICE REPRESENTATIVE (CSR). THE PATIENT ALLEGED THAT THE ISSUE BEGAN ON (B)(6) 2013, (AT 7:30AM). THE PATIENT MANAGES HER DIABETES WITH LANTUS AND NOVOLOG (2 UNITS); HOWEVER, THE PATIENT DENIED TAKING ANY ACTION IN RESPONSE TO THE ALLEGED METER ISSUE. ACCORDING TO THE CSR¿S DOCUMENTATION, APPROXIMATELY 15 MINUTES AFTER THE ALLEGED METER ISSUE OCCURRED, THE PATIENT REPORTEDLY DEVELOPED SYMPTOMS OF SHAKING, SWEATING, AND COULD NOT SEE; THE PATIENT REPORTEDLY WAS TREATED (BY A NON-HEALTH CARE PROFESSIONAL) WITH AN INCREASED DOSE OF NOVOLOG (4UNITS) AND LANTUS (DOSAGE NOT SPECIFIED) AT AN UNSPECIFIED TIME THAT MORNING. THE PATIENT¿S LAST BLOOD GLUCOSE RESULT PRIOR TO THE START OF THE ALLEGED ISSUE IS NOT KNOWN AND IT IS NOT SPECIFIED WHEN THE PATIENT¿S REPORTED BLOOD GLUCOSE SYMPTOMS ABATED. AT THE TIME OF TROUBLESHOOTING, THE CSR VERIFIED THE PATIENT WAS NOT USING THE SUBJECT METER FOR THE FIRST TIME, THE PATIENT WAS USING THE PROPER TESTING PROCEDURE (PER OWNER¿S BOOKLET RECOMMENDATION), AND THE TEST STRIP COMPLETE DREW IN THE PATIENT¿S BLOOD SAMPLE; HOWEVER, THE ALLEGED METER ISSUE REMAINS UNRESOLVED. THIS COMPLAINT IS BEING REPORTED BECAUSE THE PATIENT REPORTEDLY SUFFERED SYMPTOMS SUGGESTIVE OF A SERIOUS INJURY AFTER THE ALLEGED PRODUCT ISSUE BEGAN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    302667 OT ULTRA2 METER GLUCOSE MONITORING SYS/KIT NBW LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL 3431629

    Patients

    Seq Age Sex Outcome Treatment
    1 88 YR Life Threatening| R