BEUDAMED
    FDA Adverse Event Injury Summary report: N

    OT ULTRA EASY

    MDR report key: 1844448 · Received September 25, 2010

    Report

    Report Number
    2939301-2010-08448
    Event Type
    Injury
    Date Received
    September 25, 2010
    Date of Event
    September 3, 2010
    Report Date
    September 17, 2010
    Manufacturer
    LIFESCAN, INC.
    Product Code
    NBW
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    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.510K#: K061118.

    Description of Event or Problem · 1

    ON (B)(6), 2010 THE LAY USER/PATIENT IN (B)(6) CONTACTED LIFESCAN TO REPORT THE ONE TOUCH ULTRAEASY METER WAS GIVING AN UNSPECIFIED ERROR MESSAGE. 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 OBTAINED DURING THE INITIAL TELEPHONE CALL. ON APPROXIMATELY (B)(6), 2010 THE PATIENT OBTAINED AN ERROR MESSAGE ON THE REPORTED METER; HE WAS UNABLE TO SPECIFY WHICH ERROR MESSAGE OCCURRED. THE PATIENT WAS UNABLE TO OBTAIN A BLOOD GLUCOSE READING. ON APPROXIMATELY (B)(6), 2010 THE PATIENT EXPERIENCED THE SYMPTOMS OF DIZZINESS AND SWEATING DURING THE NIGHT. THE PATIENT CLAIMED HE HAD CHANGED HIS INSULIN REGIMEN AND TAKES 8 TO 16 UNITS "LEBROLOG" INSULIN AND 16 TO 24 UNITS LEVEMIR INSULIN. IT WOULD HAVE BEEN HELPFUL TO DETERMINE IF THE PATIENT ATTEMPTED TO TEST USING THE REPORTED METER WHILE SYMPTOMATIC, THE MEALS AND MEDICATIONS TAKEN PRIOR TO THE ONSET OF SYMPTOMS, THE PATIENT'S MEDICATION REGIMEN, HIS EXPECTED BLOOD GLUCOSE LEVELS, AND IF THE PATIENT RECEIVED ANY MEDICAL ATTENTION OR TREATMENT FOR HIS SYMPTOMS. THE ISSUE WAS NOT RESOLVED WITH TROUBLESHOOTING. THE METER, TEST STRIPS AND CONTROL SOLUTION WERE REPLACED. THE PATIENT ALLEGEDLY SUFFERED SYMPTOMS SUGGESTING SEVERE HYPOGLYCEMIA AFTER HE WAS UNABLE TO TEST HIS BLOOD GLUCOSE LEVELS DUE TO THE METER ISSUE. THEREFORE THIS COMPLAINT IS BEING REPORTED.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 69 YR Life Threatening