BEUDAMED
    FDA Adverse Event Injury Summary report: N

    OT ULTRA2 METER

    MDR report key: 2120764 · Received June 10, 2011

    Report

    Report Number
    2939301-2011-04764
    Event Type
    Injury
    Date Received
    June 10, 2011
    Report Date
    May 27, 2011
    Manufacturer
    LIFESCAN INC.
    Product Code
    NBW
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    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 K053529.

    Description of Event or Problem · 1

    ON (B)(6) 2011, THE LAY USER/ PATIENT CONTACTED LIFESCAN (LFS) ALLEGING HIS ONETOUCH ULTRA2 METER DISPLAYED A "NOT ENOUGH BLOOD" MESSAGE. THE COMPLAINT WAS CLASSIFIED BASED ON THE CUSTOMER CARE ADVOCATE (CCA) DOCUMENTATION. THE ALLEGED ISSUE BEGAN IN THE FIRST COUPLE WEEKS OF (B)(6) 2011. THE CCA WAS ADVISED THE PATIENT MANAGES HIS DIABETES WITH INSULIN (TYPE/ AMOUNT NOT SPECIFIED). THE PATIENT STATED HE INCREASED HIS USUAL DOSE OF MEDICATION. AFTER THE ALLEGED ISSUE BEGUN, THE PATIENT CLAIMED HE FELT "HYPOGLYCEMIC" SYMPTOMS. THE PATIENT WENT TO THE EMERGENCY ROOM (ER) AND OBTAINED A BLOOD GLUCOSE RESULT OF "35 MG/DL" WITH THE ER/ HOSPITAL METER. THE PATIENT WAS GIVEN GLUCOSE TABLET/ GLUCOSE GEL AS TREATMENT. AT THE TIME OF TROUBLESHOOTING, THE CCA WALKED THE PATIENT THROUGH RESOLVING THE ALLEGED ISSUE. THIS COMPLAINT IS BEING REPORTED BECAUSE THE PATIENT REPORTEDLY DEVELOPED SYMPTOMS SUGGESTIVE OF SEVERE HYPOGLYCEMIA AND 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
    1 OT ULTRA2 METER GLUCOSE MONITORING SYS/KIT NBW LIFESCAN INC. 3070436

    Patients

    Seq Age Sex Outcome Treatment
    1 62 YR Life Threatening| R