BEUDAMED
    FDA Adverse Event Injury Summary report: N

    OT ULTRA METER

    MDR report key: 2112177 · Received June 3, 2011

    Report

    Report Number
    2939301-2011-04544
    Event Type
    Injury
    Date Received
    June 3, 2011
    Date of Event
    May 17, 2011
    Report Date
    May 18, 2011
    Manufacturer
    LIFESCAN INC.
    Product Code
    NBW
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AZ, US
    Reporter Occupation
    PATIENT

    Narratives

    Additional Manufacturer Narrative · 1

    LIFESCAN (LFS) HAS REQUESTED RETURN OF THE SUBJECT PRODUCT(S) FOR EVALUATION. IF THE PRODUCT(S) ARE RETURNED, LFS WILL EVALUATE IT/THEM AND INFORM FDA OF PRODUCT(S) THAT DO NOT PASS INSPECTION IN A SUPPLEMENTAL REPORT. 510(K) # IS K062195.

    Description of Event or Problem · 1

    ON (B)(6) 2011, THE LAY USER/ PATIENT CONTACTED LIFESCAN (LFS) ALLEGING HER ONETOUCH ULTRA METER DISPLAYED HER BLOOD GLUCOSE RESULT IN THE INCORRECT UNIT OF MEASUREMENT, MMOL/L. THE MEDICAL SURVEILLANCE SPECIALIST (MSS) WAS UNABLE TO REACH THE LAY USER/PATIENT FOR FOLLOW-UP QUESTIONS. THE FOLLOWING COMPLAINT WAS CLASSIFIED BASED ON INFORMATION OBTAINED FROM LIFESCAN CUSTOMER SERVICE. THE ALLEGED ISSUE BEGAN ON (B)(6) 2011 AT 430PM. THE CUSTOMER CARE ADVOCATE (CCA) WAS ADVISED THE PATIENT MANAGES HER DIABETES WITH INSULIN (TYPE/ AMOUNT NOT SPECIFIED). IT IS NOT KNOWN WHAT ACTION THE PATIENT TOOK AT THE TIME OF THE ALLEGED ISSUE. ABOUT 45 MINUTES AFTER THE ALLEGED ISSUE BEGUN, THE PATIENT CLAIMED SHE FELT SYMPTOMS OF SHAKY, "UNABLE TO FUNCTION" AND LIGHT HEADED. THE PATIENT TOOK FOOD AND/ OR DRANK A BEVERAGE AS TREATMENT. AT THE TIME OF TROUBLESHOOTING, THE CCA NOTED IT WAS NOT THE FIRST TIME THE SUBJECT METER WAS BEING USED FOR TESTING. THE PATIENT CONFIRMED THE UNIT OF MEASUREMENT WAS PREVIOUSLY SET CORRECTLY. THE CCA EDUCATED THE PATIENT ABOUT USING EXPIRED TEST STRIPS. REPLACEMENT PRODUCTS WERE SENT TO THE PATIENT. THIS COMPLAINT IS BEING REPORTED BECAUSE THE PATIENT REPORTEDLY DEVELOPED SYMPTOMS SUGGESTIVE OF A SERIOUS INJURY AFTER THE ALLEGED METER ISSUE BEGAN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 OT ULTRA METER GLUCOSE MONITORING SYS/KIT NBW LIFESCAN INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 Life Threatening| R