BEUDAMED
    FDA Adverse Event Injury Summary report: N

    OT ULTRA METER

    MDR report key: 1853169 · Received October 5, 2010

    Report

    Report Number
    2939301-2010-08764
    Event Type
    Injury
    Date Received
    October 5, 2010
    Date of Event
    September 14, 2010
    Report Date
    September 16, 2010
    Manufacturer
    LIFESCAN, INC.
    Product Code
    NBW
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    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. A 510(K) # IS K062195.

    Description of Event or Problem · 1

    ON (B)(6) 2010, THE LAY USER/ PATIENT CONTACTED LIFESCAN (LFS) ALLEGING HIS ONETOUCH ULTRA METER CONTINUED TO REVERT TO THE SET UP MODE. THE COMPLAINT WAS CLASSIFIED BASED ON THE CUSTOMER CARE ADVOCATE (CCA) DOCUMENTATION. THE PATIENT REPORTED THE ALLEGED ISSUE BEGAN ON (B)(6) 2010. THE PATIENT ADVISED THE CCA HE MANAGES HIS DIABETES WITH INSULIN (TYPE NOT SPECIFIED). AT THE TIME OF THE ALLEGED ISSUE, THE PATIENT STATED HE DECREASED HIS INSULIN DOSE FROM 40 UNITS TO 20 UNITS. ON THE EARLY MORNING OF (B)(6) 2010, THE PATIENT CLAIMED HE FELT SYMPTOMS OF "SWEAT AND PANIC." THE PATIENT STATED HE IMMEDIATELY TOOK FOOD AND/ OR DRANK A BEVERAGE AS TREATMENT. AT THE TIME OF TROUBLESHOOTING, THE CCA NOTED THERE WAS NO MISUSE OF THE SUBJECT METER. THE PATIENT STATED HE DID NOT RECENTLY REMOVE OR REPLACE THE BATTERIES TO CAUSE AN INTERRUPTION IN POWER. REPLACEMENT PRODUCTS WERE SENT TO THE PATIENT. THIS COMPLAINT IS BEING REPORTED BECAUSE THE PATIENT CLAIMS HE WAS UNABLE TO TEST HIS BLOOD GLUCOSE DUE TO THE REPORTED ISSUE AND REPORTEDLY DEVELOPED SYMPTOMS SUGGESTIVE OF SEVERE HYPOGLYCEMIA 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. 2675963

    Patients

    Seq Age Sex Outcome Treatment
    1 58 YR Life Threatening| R