BEUDAMED
    FDA Adverse Event Injury Summary report: N

    OT ULTRALINK METER

    MDR report key: 3141399 · Received June 3, 2013

    Report

    Report Number
    3008382007-2013-14077
    Event Type
    Injury
    Date Received
    June 3, 2013
    Date of Event
    May 7, 2013
    Report Date
    May 9, 2013
    Manufacturer
    LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL
    Product Code
    NBW
    PMA / PMN Number
    K073231
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NE, US
    Reporter Occupation
    PATIENT

    Narratives

    Additional Manufacturer Narrative · 1

    THE METER AND TEST STRIPS INVOLVED WITH THIS COMPLAINT HAVE BEEN RETURNED AND EVALUATED BY LIFESCAN PRODUCT ANALYSIS ON (B)(4) 2013, RESPECTIVELY, WITH THE FOLLOWING FINDINGS: THE METER PASSED ALL TESTING WITH NO FAULTS FOUND. THE TEST STRIPS WERE ALSO TESTED AND THE PRIMARY COMPLAINT WAS NOT CONFIRMED. IF LIFESCAN OBTAINS ADDITIONAL INFORMATION REGARDING THIS COMPLAINT, A FOLLOW UP REPORT WILL BE SUBMITTED.

    Description of Event or Problem · 1

    ON (B)(6) 2013, THE LAY USER/ PATIENT CONTACTED LIFESCAN (LFS) ALLEGING HER ONETOUCH ULTRALINK METER DISPLAYED AN ¿ERROR 2¿ MESSAGE. THE COMPLAINT WAS CLASSIFIED BASED ON THE CUSTOMER CARE ADVOCATE (CCA) DOCUMENTATION. THE ALLEGED ISSUE BEGAN ON (B)(6) 2013 AT 5PM. THE PATIENT MANAGES HER DIABETES WITH INSULIN PUMP THERAPY. THE PATIENT REPORTEDLY SUSPENDED HER USUAL DOSE OF INSULIN UNTIL HER BLOOD GLUCOSE RESULTS WENT BACK UP. SYMPTOMS WERE NOT SPECIFIED. EMERGENCY MEDICAL SERVICES (EMS) WAS REPORTEDLY CONTACTED AND ADMINISTERED THE PATIENT GLUCOSE TABLETS/ GLUCOSE GEL AS TREATMENT. THE PATIENT OBTAINED A BLOOD GLUCOSE RESULT OF ¿43 MG/DL¿ WITH THE EMS METER. AT THE TIME OF TROUBLESHOOTING, THE CCA NOTED THE CORRECT TEST STRIPS WERE BEING USED FOR TESTING AND THERE WAS NO INDICATION OF MISUSE. THE CCA WALKED THE PATIENT THROUGH A RETEST TO RESOLVE THE ALLEGED ISSUE. REPLACEMENT PRODUCTS WERE SENT TO THE PATIENT. THIS COMPLAINT IS BEING REPORTED BECAUSE THE PATIENT MAY HAVE RECEIVED MEDICAL INTERVENTION FROM A HEALTH CARE PROFESSIONAL (HCP) AFTER THE REPORTED ISSUE BEGAN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    243750 OT ULTRALINK METER GLUCOSE MONITORING SYS/KIT NBW LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL 3431629

    Patients

    Seq Age Sex Outcome Treatment
    1 70 YR Life Threatening| R