BEUDAMED
    FDA Adverse Event Injury Summary report: N

    OT ULTRA METER

    MDR report key: 2133021 · Received June 17, 2011

    Report

    Report Number
    2939301-2011-04956
    Event Type
    Injury
    Date Received
    June 17, 2011
    Date of Event
    June 7, 2011
    Report Date
    June 9, 2011
    Manufacturer
    LIFESCAN INC.
    Product Code
    NBW
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, 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 K062195.

    Description of Event or Problem · 1

    ON (B)(6) 2011, THE LAY USER/ PATIENT CONTACTED LIFESCAN (LFS) ALLEGING HIS ONETOUCH ULTRA METER CONTINUES TO POWER OFF DURING USE. THE MEDICAL SURVEILLANCE SPECIALIST (MSS) SPOKE WITH THE PATIENT ON (B)(6) 2011 AND OBTAINED THE FOLLOWING INFORMATION. THE MSS WAS ADVISED THE PATIENT TESTS HIS BLOOD GLUCOSE 2-3X A DAY. THE PATIENT MANAGES HIS DIABETES WITH HUMALOG INSULIN (WITH MEALS) AND LANTUS INSULIN (60 UNITS IN THE MORNING/ 38 UNITS IN THE EVENING). THE ALLEGED ISSUE BEGAN ON THE MORNING OF (B)(6) 2011. THE PATIENT DENIED MAKING CHANGES TO HIS DIABETES MANAGEMENT ROUTINE. LATER IN THE EVENING, THE PATIENT CLAIMED HE FELT HIGH BLOOD GLUCOSE SYMPTOMS OF SWEATY, DIZZY, FREQUENT URINATION AND INCREASED BOWEL MOVEMENTS. THAT SAME EVENING, THE PATIENT WENT TO THE EMERGENCY ROOM (ER). THE PATIENT OBTAINED A "HIGH" BLOOD GLUCOSE READING ON THE ER/ HOSPITAL DEVICE BUT COULD NOT SPECIFY THE RESULT. A HEALTH CARE PROFESSIONAL (HCP) ADMINISTERED THE PATIENT INSULIN (TYPE/AMOUNT NOT SPECIFIED) AS TREATMENT. THE PATIENT STATED HE FELT BETTER AFTER. AT THE TIME OF TROUBLESHOOTING, THE CUSTOMER CARE ADVOCATE (CCA) NOTED THERE WAS NO MISUSE OF THE SUBJECT METER. THE CCA WAS UNABLE TO WALK THE PATIENT THROUGH RESOLVING THE ALLEGED ISSUE. REPLACEMENT PRODUCTS WERE SENT TO THE PATIENT. THIS COMPLAINT IS BEING REPORTED BECAUSE THE PATIENT REPORTEDLY DEVELOPED SYMPTOMS SUGGESTIVE OF HYPERGLYCEMIA 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 ULTRA METER GLUCOSE MONITORING SYS/KIT NBW LIFESCAN INC. 3132194

    Patients

    Seq Age Sex Outcome Treatment
    1 50 YR Life Threatening| R