BEUDAMED
    FDA Adverse Event Injury Summary report: N

    OT ULTRA METER

    MDR report key: 2083342 · Received May 10, 2011

    Report

    Report Number
    2939301-2011-03843
    Event Type
    Injury
    Date Received
    May 10, 2011
    Report Date
    April 30, 2011
    Manufacturer
    LIFESCAN INC.
    Product Code
    NBW
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NC, 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 CONTINUED TO REVERT TO THE SETUP MODE WHEN TRYING TO PERFORM A BLOOD GLUCOSE TEST. THE COMPLAINT WAS CLASSIFIED BASED ON THE CUSTOMER CARE ADVOCATE (CCA) DOCUMENTATION. THE ALLEGED ISSUE BEGAN A COUPLE WEEKS AGO PRIOR TO CONTACTING LFS. THE CCA WAS ADVISED THE PATIENT MANAGES HER DIABETES WITH METFORMIN PILLS (1000 MG 2X DAILY), ACTOS PILLS (45 MG) AND LANTUS INSULIN (30 UNITS). THE PATIENT STATED SHE CONTINUED TO TAKE HER USUAL DOSE OF MEDICATIONS; HOWEVER, A LITTLE MORE THAN A WEEK PRIOR TO CONTACTING LFS, THE PATIENT ADMINISTERED SELF 6 UNITS LANTUS INSULIN AT NIGHT. ABOUT 2-3 DAYS AGO PRIOR TO CONTACTING LFS, THE PATIENT CLAIMED SHE FELT SYMPTOMS OF DIZZY, SHAKY AND SWEATY. AT THE TIME OF TROUBLESHOOTING, THE CCA NOTED THERE WAS NO MISUSE OF THE SUBJECT METER. THE PATIENT CONFIRMED THE ALLEGED ISSUE OCCURRED AFTER REMOVING/ REPLACING THE BATTERIES. THE CCA WALKED THE PATIENT THROUGH RESOLVING THE ALLEGE DISUSE. 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. 3072965

    Patients

    Seq Age Sex Outcome Treatment
    1 73 YR Life Threatening