BEUDAMED
    FDA Adverse Event Injury Summary report: N

    OT ULTRA2 METER

    MDR report key: 1880470 · Received October 22, 2010

    Report

    Report Number
    2939301-2010-09323
    Event Type
    Injury
    Date Received
    October 22, 2010
    Report Date
    October 20, 2010
    Manufacturer
    LIFESCAN, INC.
    Product Code
    NBW
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AG
    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.THE 510K #K053529.

    Description of Event or Problem · 1

    THE MEDICAL SURVEILLANCE SPECIALIST (MSS) CLASSIFIED THIS COMPLAINT BASED ON CUSTOMER SERVICE REPRESENTATIVE (CSR) DOCUMENTATION. ON (B)(6) 2010, THE LAY-USER/PATIENT CONTACTED LIFESCAN (LFS) ALLEGING THAT THE ONETOUCH ULTRA2 METER WILL NOT POWER ON. THE PATIENT'S DIABETES IS MANAGED WITH ORAL MEDICATION AND INSULIN. THE PATIENT TAKES GLUCOPHAGE DURING LUNCH AND "ASPEGIC" AT NIGHT BEFORE BEDTIME. IN ADDITION, HIS DAILY INSULIN INTAKE IS 18 UNITS AT 8 AM AND 12 UNITS AT 6 PM. AFTER THE POWER ISSUE BEGAN AROUND (B)(6) 2010, THE PATIENT REPORTEDLY COULD NOT TEST HIS BLOOD GLUCOSE. HE DID NOT MAKE ANY ALTERATION TO HIS DIABETES MANAGEMENT DUE TO THE PRODUCT ISSUE. THE PATIENT REPORTEDLY WAS UNABLE TO TEST WITH THE SUBJECT METER FOR 2 WEEKS AND DEVELOPED SYMPTOMS OF "SWEATING." THERE WAS NO ALLEGATION OF MEDICAL TREATMENT FOR SEVERE HYPOGLYCEMIA OR HYPERGLYCEMIA. ACCORDING TO THE TROUBLESHOOTING PERFORMED WITH CUSTOMER SERVICE, THE POWER ISSUE WAS NOT RESOLVED WITH TRAINING. THE BATTERY WAS REPLACEMENT, BUT THE SUBJECT METER DID NOT POWER ON WITH POWER BUTTON OR THE INSERTION OF THE TEST STRIP. REPLACEMENT PRODUCTS WERE SENT TO THE PATIENT. THIS COMPLAINT IS BEING REPORTED BECAUSE THE PATIENT CLAIMED HE DEVELOPED SYMPTOM THAT CAN BE ASSOCIATED WITH HYPOGLYCEMIA AFTER HE COULD TEST HIS BLOOD GLUCOSE DUE TO THE POWER ISSUE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 OT ULTRA2 METER GLUCOSE MONITORING SYS/KIT NBW LIFESCAN, INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 63 YR Life Threatening