BEUDAMED
    FDA Adverse Event Death Summary report: N

    ONE TOUCH ULTRAMINI METER

    MDR report key: 1657999 · Received April 9, 2010

    Report

    Report Number
    2939301-2010-02672
    Event Type
    Death
    Date Received
    April 9, 2010
    Report Date
    March 10, 2010
    Manufacturer
    LIFESCAN, INC.
    Product Code
    NBW
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GR
    Reporter Occupation
    LAY USER/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.

    Description of Event or Problem · 1

    ON (B) (6) 2010, THE LAY USER/PATIENT IN GREECE CONTACTED LIFESCAN (LFS) TO REPORT AN ISSUE WITH THE BLOOD GLUCOSE READINGS OBTAINED ON THE ONE TOUCH ULTRA EASY METER. THE TECHNICAL SERVICE REPRESENTATIVE (TSR) CONTACTED THE PATIENT TO OBTAIN AND VERIFY INFORMATION; HOWEVER, WAS UNABLE TO REACH HER BY TELEPHONE. ON (B) (6) 2010, THE PATIENT OBTAINED THE BLOOD GLUCOSE READINGS OF 118 MG/DL AND 181 MG/DL ON THE REPORTED METER. THIS WAS A NEW, OUT-OF-THE BOX, METER. ON (B) (6) 2010, DURING A TELEPHONE CALL WITH CUSTOMER SERVICE, THE PATIENT CLAIMED TO BE EXPERIENCING THE SYMPTOMS OF 'HYPOGLYCEMIA.' THE PATIENT DID NOT PROVIDE HER SPECIFIC SYMPTOMS. THERE IS NO EVIDENCE THE ONSET OF SYMPTOMS OCCURRED AFTER THE METER ISSUE. ON APRIL 6, 2010, THE TSR SPOKE WITH A FAMILY MEMBER AND WAS INFORMED THE PATIENT HAD DIED. NO INFORMATION WAS PROVIDED CONCERNING THE CAUSE OF DEATH OR DATE OF DEATH. THERE WAS NO ALLEGATION THE REPORTED METER CONTRIBUTED TO THE PATIENT'S DEATH. THIS REPORT IS TO INFORM THE AUTHORITY OF THIS PATIENT'S DEATH, AND THE COMPANY WILL FOLLOW UP WITH THE PATIENT'S FAMILY MEMBERS AT A FUTURE DATE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ONE TOUCH ULTRAMINI METER GLUCOSE MONITORING SYS/KIT NBW LIFESCAN, INC. NA NI

    Patients

    Seq Age Sex Outcome Treatment
    1 81 YR Death