BEUDAMED
    FDA Adverse Event Injury Summary report: N

    OT ULTRA METER

    MDR report key: 2515651 · Received April 3, 2012

    Report

    Report Number
    2939301-2012-03245
    Event Type
    Injury
    Date Received
    April 3, 2012
    Report Date
    April 2, 2012
    Manufacturer
    LIFESCAN INC.
    Product Code
    NBW
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    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 # K062195.

    Description of Event or Problem · 1

    ON (B)(6) 2012, THE LAY-USER/PATIENT CONTACTED LIFESCAN (LFS) (B)(4) ALLEGING THE LIFESCAN METER (POSSIBLY A ONETOUCH ULTRA METER) WAS GIVING UNSPECIFIED ERROR MESSAGES. REPORTEDLY, THE PATIENT HAD TO PRICK HIS FINGERS MULTIPLE TIMES TO OBTAIN A BLOOD GLUCOSE READING. HE EVENTUALLY STOPPED TESTING DUE TO THE ISSUES AND SUBSEQUENTLY DEVELOPED DESCRIBED AS "SWEATY, DIZZY, FREQUENT URINATION, AND SHAKY." THE PATIENT WAS NOT ABLE TO PROVIDE MUCH DETAIL ABOUT THE INCIDENTS SINCE THE ISSUE HAS BEEN ONGOING FOR THE LAST FEW YEARS. REPORTEDLY, THE PATIENT HAD SIMILARLY LIFESCAN METER OVER THE YEARS. DURING TROUBLESHOOTING, THE CUSTOMER SERVICE REPRESENTATIVE WAS WALK THE CUSTOMER THROUGH A SUCCESSFUL TEST AND ENSURED HIS TECHNICAL WAS CORRECT. THIS COMPLAINT IS BEING REPORTED BECAUSE THE PATIENT ALLEGEDLY HAD SYMPTOMS SUGGESTIVE OF ACUTE COMPLICATION OF DIABETES AFTER THE PATIENT HAD ISSUES WITH THE REPORTED ERROR MESSAGE.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 Life Threatening