BEUDAMED
    FDA Adverse Event Injury Summary report: N

    OT VITA METER

    MDR report key: 2311105 · Received October 27, 2011

    Report

    Report Number
    2939301-2011-10614
    Event Type
    Injury
    Date Received
    October 27, 2011
    Date of Event
    September 7, 2011
    Report Date
    October 20, 2011
    Manufacturer
    LIFESCAN INC.
    Product Code
    NBW
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    PATIENT

    Narratives

    Additional Manufacturer Narrative · 1

    THE 510K#: K082513. (B)(6).

    Description of Event or Problem · 1

    ON (B)(6) 2011 THE LAY USER/PATIENT IN (B)(6) CONTACTED LIFESCAN TO REPORT THE ONE TOUCH VITA METER WAS GIVING INACCURATELY HIGH READINGS. THE TECHNICAL SERVICE REPRESENTATIVE (TSR) CONTACTED THE PATIENT TO OBTAIN AND VERIFY INFORMATION; HOWEVER WAS UNABLE TO REACH HIM BY TELEPHONE. THE SR. MEDICAL SURVEILLANCE SPECIALIST CLASSIFIED THE COMPLAINT BASED ON THE INFORMATION ORIGINALLY PROVIDED TO CUSTOMER SERVICE. ON (B)(6) 2011 AT 9:00 AM THE PATIENT OBTAINED A BLOOD GLUCOSE READING ON THE REPORTED METER, AND A READING ON ANOTHER METER WITHIN 30 MINUTES THAT WAS "20 MG/DL LOWER"; NO SPECIFIC DATA WAS PROVIDED. AFTER THIS TESTING, THE PATIENT FOLLOWING HIS USUAL ROUTINE; THE PATIENT TAKES NO MEDICATIONS FOR HIS DIABETES. TWO HOURS AFTERWARDS, THE PATIENT ALLEGEDLY EXPERIENCED THE SYMPTOMS OF SWEATING AND AGITATION. THE PATIENT OBTAINED A BLOOD GLUCOSE READING OF 75 MG/DL ON THE BACKUP METER. THE PATIENT ADMINISTERED SELF-TREATMENT BY CONSUMING GLUCOSE TABLETS; HE DID NOT SEEK ANY MEDICAL ATTENTION. IT WOULD HAVE BEEN HELPFUL TO DETERMINE THE SPECIFIC RESULTS OBTAINED, THE PATIENT'S EXPECTED RESULTS, WHAT ACTIONS WERE TAKEN PRIOR TO THE ONSET OF SYMPTOMS, IF THE PATIENT TESTED HIS BLOOD GLUCOSE LEVEL USING THE REPORTED METER WHILE SYMPTOMATIC, AND IF HIS SYMPTOMS WERE ABATED WITH THE CONSUMPTION OF GLUCOSE. THE METER WAS REPLACED. NO SPECIFIC DATA WAS PROVIDED ABOUT THE ALLEGEDLY INACCURATE READINGS ON THE REPORTED METER. THE PATIENT ALLEGEDLY SUFFERED SYMPTOMS SUGGESTING HYPOGLYCEMIA AFTER USING THE REPORTED METER, AND RECEIVED TREATMENT WITH GLUCOSE. THEREFORE THIS COMPLAINT IS BEING REPORTED.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 70 YR Life Threatening| R