BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ONE TOUCH ULTRA METER

    MDR report key: 1173441 · Received September 23, 2008

    Report

    Report Number
    2939301-2008-02347
    Event Type
    Injury
    Date Received
    September 23, 2008
    Date of Event
    September 4, 2008
    Report Date
    September 4, 2008
    Manufacturer
    LIFESCAN, INC.
    Product Code
    NBW
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    LIFESCAN HAS REQUESTED THE RETURN OF THE SUBJECT METER AND STRIPS FOR EVAL, BUT HAS NOT YET RECEIVED THEM. IF EITHER THE METER OR STRIPS ARE RETURNED, LIFESCAN WILL EVALUATE IT/THEM AND, IF EITHER THE METER OR STRIPS DO NOT PASS INSPECTION, LIFESCAN WILL INFORM FDA OF THE RESULTS IN A SUPPLEMENTAL REPORT.

    Description of Event or Problem · 1

    ON THE EVENT DATE, THE LAY USER/PT CONTACTED LIFESCAN (LFS) ALLEGING THAT HER ONE TOUCH ULTRA METER WOULD NOT START THE RESULT COUNTDOWN AFTER SHE APPLIED A BLOOD SAMPLE. THE FOLLOWING INFO WAS BASED ON THE CUSTOMER CARE ADVOCATE'S (CCA) DOCUMENTATION SINCE THE MEDICAL AFFAIRS SPECIALIST (MAS) WAS UNABLE TO REACH THE PT FOR A FOLLOW-UP CALL. THE PT STATED THAT THIS REPORTED ISSUE FIRST OCCURRED ON THE SAME DAY SHE CONTACTED LFS BUT THE TIME WAS NOT SPECIFIED. AT AN UNSPECIFIED TIME AFTER THE ISSUE BEGAN, SHE REPORTEDLY DEVELOPED SYMPTOMS OF FEELING SHAKY, NO ENERGY, AND FAINT. IT WOULD BE HELPFUL TO KNOW HOW LONG AFTER THE ISSUE BEGAN DID SHE DEVELOP THE REPORTED SYMPTOMS. IT WOULD ALSO HAVE BEEN HELPFUL TO KNOW WHAT ACTIONS WERE TAKEN BEFORE SHE DEVELOPED THE REPORTED SYMPTOMS SUCH AS HER ACTIVITY LEVELS, MEDICATIONS, PREVIOUS METER READINGS, AND PREVIOUS METER READINGS. AT AN UNSPECIFIED TIME, SHE ATE AND THEN TESTED ON HER NEIGHBOR'S METER, WHICH READ "119 MG/DL." IT IS UNKNOWN IF HER SYMPTOMS WERE RELIEVED AFER EATING. THE PT DENIED RECEIVING ANY OTHER TYPES OF MEDICAL INTERVENTION AS A RESULT OF THE REPORTED ISSUE. THE CUSTOMER CARE ADVOCATE (CCA) WENT THROUGH TROUBLESHOOTING WITH THE PT AND WAS UNABLE TO RESOLVE THE ISSUE. REPLACEMENT PRODUCTS WERE SENT TO THE PT. BASED ON THE PROVIDED INFO, THIS COMPLAINT IS BEING REPORTED BECAUSE THE PT REPORTEDLY DEVELOPED SYMPTOMS SUGGESTIVE OF HYPOGLYCEMIA AFTER THE REPORTED ISSUE BEGAN. IN ADDITION, THE REPORTED ISSUE WAS NOT RESOLVED WITH TROUBLESHOOTING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ONE TOUCH ULTRA METER GLUCOSE MONITORING SYS/KIT NBW LIFESCAN, INC. NA 2788086

    Patients

    Seq Age Sex Outcome Treatment
    1 52 YR Life Threatening| R