BEUDAMED
    FDA Adverse Event Injury Summary report: N

    OT ULTRA METER

    MDR report key: 2213069 · Received August 16, 2011

    Report

    Report Number
    2939301-2011-07496
    Event Type
    Injury
    Date Received
    August 16, 2011
    Date of Event
    July 11, 2011
    Report Date
    July 29, 2011
    Manufacturer
    LIFESCAN INC.
    Product Code
    NBW
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WA, 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. THE 510K # IS K001109.

    Description of Event or Problem · 1

    ON (B)(6) 2011, THE LAY USER/PATIENT CONTACTED LIFESCAN TO REPORT THE ONE TOUCH ULTRA METER WAS DISPLAYING THE BATTERY INDICATOR SYMBOL. THE SR. MEDICAL SURVEILLANCE SPECIALIST WAS ABLE TO CLASSIFY THE COMPLAINT BASED ON THE INFORMATION PROVIDED TO CUSTOMER SERVICE. ON (B)(6) 2011, THE PATIENT NOTED THE REPORTED METER WOULD NOT POWER ON; SHE WAS UNABLE TO OBTAIN A BLOOD GLUCOSE READING. THE METER WILL DISPLAY THE BATTERY SYMBOL WHEN THERE IS NO LONGER ENOUGH POWER TO PERFORM A TEST; THE BATTERY MUST BE REPLACED. THE PATIENT TOOK NO ACTIONS DUE TO THIS METER ISSUE. THE PATIENT MANAGES HER DIABETES WITH SET DOSES OF INSULIN. THREE DAYS AFTERWARDS, THE PATIENT EXPERIENCED THE SYMPTOM OF SWEATING. THE PATIENT DID NOT SEEK ANY MEDICAL ATTENTION OR TREATMENT. TROUBLESHOOTING REVEALED THE PATIENT HAD NOT REPLACED THE METER'S BATTERY AS RECOMMENDED BY THE MANUFACTURER. THE ISSUE WAS NOT RESOLVED, AS THE PATIENT DID NOT HAVE A NEW REPLACEMENT BATTERY AVAILABLE. THE METER, TEST STRIPS AND CONTROL SOLUTION WERE REPLACED. THE PATIENT HAD NOT REPLACED THE METER'S BATTERY AS RECOMMENDED. THE PATIENT ALLEGEDLY SUFFERED SYMPTOMS SUGGESTING SEVERE HYPOGLYCEMIA AFTER SHE WAS UNABLE TO TEST HER BLOOD GLUCOSE LEVELS DUE TO THE METER POWER ISSUE. THEREFORE, THIS COMPLAINT IS BEING REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 OT ULTRA METER GLUCOSE MONITORING SYS/KIT NBW LIFESCAN INC. 2972879

    Patients

    Seq Age Sex Outcome Treatment
    1 66 YR Life Threatening