BEUDAMED
    FDA Adverse Event Injury Summary report: N

    OT ULTRAMINI

    MDR report key: 1869945 · Received October 14, 2010

    Report

    Report Number
    2939301-2010-09051
    Event Type
    Injury
    Date Received
    October 14, 2010
    Date of Event
    October 1, 2010
    Report Date
    October 1, 2010
    Manufacturer
    LIFESCAN, INC.
    Product Code
    NBW
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MO, 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. 510(K) # IS K061118.

    Description of Event or Problem · 1

    ON (B)(6) 2010, THE LAY USER/PATIENT CONTACTED LIFESCAN TO REPORT THE ONE TOUCH ULTRAMINI METER WAS GIVING THE ERROR 2 ERROR MESSAGE. THE SR. MEDICAL SURVEILLANCE SPECIALIST WAS ABLE TO CLASSIFY THE COMPLAINT BASED ON THE INFORMATION PROVIDED. ON THE MORNING OF (B)(6) 2010, THE PATIENT OBTAINED THE ERROR MESSAGE ERROR 2 ON THE REPORTED METER; SHE WAS UNABLE TO OBTAIN A BLOOD GLUCOSE READING. AFTER THE USE OF THE METER, THE PATIENT CONSUMED LESS FOOD AND/OR DRINK. A FEW MINUTES AFTERWARDS, THE PATIENT EXPERIENCED THE SYMPTOM OF SHAKING. SHE DID NOT SEEK ANY MEDICAL ATTENTION OR TREATMENT. TROUBLESHOOTING REVEALED THE PATIENT'S TESTING TECHNIQUE AND TEST STRIPS WERE CORRECT. THE ISSUE WAS NOT RESOLVED. THE PATIENT MANAGES HER DIABETES WITH INSULIN TAKEN ON A SLIDING SCALE. THE METER, TEST STRIPS AND CONTROL SOLUTION WERE REPLACED. THE PATIENT ALLEGEDLY SUFFERED SYMPTOMS SUGGESTING SEVERE HYPOGLYCEMIA AFTER SHE WAS UNABLE TO OBTAIN A BLOOD GLUCOSE READING DUE TO THE METER ISSUE. THEREFORE THIS COMPLAINT IS BEING REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 OT ULTRAMINI GLUCOSE MONITORING SYS/KIT NBW LIFESCAN, INC. 3038411

    Patients

    Seq Age Sex Outcome Treatment
    1 69 YR Life Threatening