BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ONE TOUCH ULTRASMART METER

    MDR report key: 1231907 · Received November 12, 2008

    Report

    Report Number
    2939301-2008-03062
    Event Type
    Injury
    Date Received
    November 12, 2008
    Date of Event
    October 31, 2008
    Report Date
    October 31, 2008
    Manufacturer
    LIFESCAN, INC.
    Product Code
    NBW
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GA, US
    Reporter Occupation
    LAY USER/PATIENT

    Narratives

    Additional Manufacturer Narrative · 1

    LIFESCAN HAS REQUESTED THE RETURN OF THE SUBJECT METER AND STRIPS FOR EVALUATION, 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

    IN 2008, THE LAY USER/PATIENT CONTACTED LIFESCAN (LFS) ALLEGING A POWER ISSUE (DOES NOT TURN ON) WITH HER ONETOUCH ULTRASMART METER. THE PATIENT STATED THAT THE METER WAS JUST 2 WEEKS OLD BUT IT WAS NOT SPECIFIED WHEN THE POWER ISSUE FIRST OCCURRED. IT IS ALSO UNK IF THE PATIENT MADE ANY CHANGES OR CONTINUED HER USUAL DIABETES MANAGEMENT ROUTINE AFTER POWER ISSUE BEGAN. THE CUSTOMER CARE ADVOCATE (CCA) WENT THROUGH TROUBLESHOOTING WITH THE PATIENT AND CONFIRMED THAT THE METER WOULD NOT POWER ON BY PRESSING ANY OF THE POWER BUTTONS OR BY INSERTING A TEST STRIP. THE CCA ALSO NOTED THAT THERE WAS NO MISUSE OS THE PRODUCT. DURING TROUBLESHOOTING, THE PATIENT REPORTEDLY DEVELOPED SYMPTOMS OF FEELING LOW (SHAKINESS) SO THE CCA DISCONNECTED THE CALL IN ORDER FOR THE PATIENT TO TAKE CARE OF HERSELF. THE MEDICAL AFFAIRS SPECIALISTS (MAS) WAS UNABLE TO REACH THE PATIENT FOR ADDITIONAL INFO. IT WOULD BE HELPFUL TO KNOW HOW MUCH TIME PASSED FROM WHEN THE POWER ISSUE BEGAN TO WHEN HER SYMPTOMS STARTED AND WHAT EVENTS MAY HAVE LED TO HER SYMPTOMS. IT WOULD ALSO BE HELPFUL TO KNOW IF THE SYMPTOMS WERE TREATED AFTER THE PATIENT GOT OFF THE PHONE THE CCA. BASED ON THE PROVIDED INFO, THIS COMPLAINT IS BEING REPORTED BECAUSE THE PATIENT ALLEGEDLY BECAME SHAKY AFTER THE POWER ISSUE BEGAN. REPLACEMENT PRODUCTS WERE SENT TO THE PATIENT.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 Life Threatening