BEUDAMED
    FDA Adverse Event Injury Summary report: N

    OT ULTRA METER

    MDR report key: 2863432 · Received December 10, 2012

    Report

    Report Number
    3008382007-2012-07377
    Event Type
    Injury
    Date Received
    December 10, 2012
    Date of Event
    November 8, 2012
    Report Date
    November 12, 2012
    Manufacturer
    LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL
    Product Code
    NBW
    PMA / PMN Number
    K062195
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    PATIENT

    Narratives

    Additional Manufacturer Narrative · 1

    TEST STRIP LOT #: NOT PROVIDED.

    Description of Event or Problem · 1

    ON (B)(6) 2012, THE LAY USER/PATIENT CONTACTED LIFESCAN (LFS) ALLEGING HE WAS UNABLE TO CODE HIS ONETOUCH ULTRA METER. THE FOLLOWING COMPLAINT WAS CLASSIFIED BASED ON INFORMATION OBTAINED FROM THE CUSTOMER SERVICE REPRESENTATIVE (CSR). THE PATIENT ALLEGED THAT THE ISSUE BEGAN ON EITHER (B)(6) 2012 (BETWEEN 9AM-12PM). IN ADDITION TO ORAL MEDICATION (TYPE AND DOSE UNSPECIFIED), THE PATIENT STATED HE ALSO MANAGES HIS DIABETES WITH DIET AND/OR EXERCISE. IN RESPONSE TO THE ALLEGED ISSUE, THE PATIENT CLAIMED HE CONSUMED LESS FOOD/DRINK ON (B)(6), 2012 (BETWEEN 9AM-12PM). THE PATIENT DENIED TESTING HIS BLOOD GLUCOSE WITH ANOTHER DEVICE. ACCORDING TO THE CSR'S DOCUMENTATION, AS A RESULT OF THE ALLEGED ISSUE THE PATIENT REPORTEDLY DEVELOPED SYMPTOMS ARE DIZZINESS AND BLURRY VISION ON TWO DIFFERENT OCCASIONS ((B)(6) 2012 AT 1:30PM AND ON (B)(6) 2012 AT 10:45AM). THE PATIENT REPORTEDLY ADMINISTERED SELF-TREATMENT BY CONSUMING AN ADDITIONAL PILL OF GLUCOPHAGE AND GLYBURIDE ON (B)(6) 2012 (TIME NOT SPECIFIED). DURING TROUBLESHOOTING, THE CSR NOTED THE ALLEGED ISSUE WAS RESOLVED WITH TRAINING. THE PATIENT AGREED TO NOT HAVE HIS PRODUCTS REPLACED. THE CSR ALSO NOTED THAT THE PATIENT WAS NOT STORING HIS TEST STRIPS PROPERLY; THE PATIENT WAS REMOVING THE TEST STRIPS OUT OF THE VIAL AND PLACING THE STRIPS IN SNACK BAG. THE PATIENT DID NOT HAVE THE TEST STRIP VIAL AVAILABLE. 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 HYPERGLYCEMIA 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 EUROPE, A DIVISION OF CILAG GMBH INTL

    Patients

    Seq Age Sex Outcome Treatment
    1 62 YR Life Threatening