BEUDAMED
    FDA Adverse Event Injury Summary report: N

    OT ULTRA2 METER

    MDR report key: 1841808 · Received September 22, 2010

    Report

    Report Number
    2939301-2010-08298
    Event Type
    Injury
    Date Received
    September 22, 2010
    Date of Event
    September 2, 2010
    Report Date
    September 3, 2010
    Manufacturer
    LIFESCAN, INC.
    Product Code
    NBW
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, 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.AGE: NOT PROVIDED.GENDER: NOT PROVIDED.THE 510K#: K053529.

    Description of Event or Problem · 1

    ON SEPTEMBER 3, 2010, THE LAY USER/PATIENT CONTACTED LIFESCAN (LFS) TO REPORT THE ONE TOUCH ULTRA 2 METER WAS GIVING INACCURATELY ERRATIC READINGS. THE SR. MEDICAL SURVEILLANCE SPECIALIST WAS ABLE TO CLASSIFY THE COMPLAINT BASED ON THE INFORMATION PROVIDED. ON (B)(6) 2010, THE PATIENT OBTAINED THE BLOOD GLUCOSE READINGS OF 110 MG/DL AND 177 MG/DL OVER AN UNSPECIFIED TIME PERIOD. THE PATIENT TOOK NO ACTIONS DUE TO THESE READINGS. ON (B)(6) 2010 AT 3:45 PM, THE PATIENT EXPERIENCED THE SYMPTOMS OF HUNGER, SWEATING AND SHAKING. THE PATIENT DID NOT SEEK ANY MEDICAL ATTENTION OR TREATMENT. THE PATIENT MANAGES HIS DIABETES WITH INSULIN. TROUBLESHOOTING REVEALED THE PATIENT'S TESTING TECHNIQUE WAS CORRECT AND THE TEST STRIPS WERE IN GOOD CONDITION AND WITHIN OPENED EXPIRATION DATING. THE METER WAS REPLACED. THE PATIENT ALLEGEDLY SUFFERED SYMPTOMS SUGGESTING SEVERE HYPOGLYCEMIA AFTER OBTAINING ELEVATED METER READINGS. THEREFORE THIS COMPLAINT IS BEING REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 OT ULTRA2 METER GLUCOSE MONITORING SYS/KIT NBW LIFESCAN, INC. 3020075

    Patients

    Seq Age Sex Outcome Treatment
    1 Life Threatening