BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ONE TOUCH ULTRASMART METER

    MDR report key: 1192396 · Received October 6, 2008

    Report

    Report Number
    2939301-2008-02546
    Event Type
    Injury
    Date Received
    October 6, 2008
    Date of Event
    September 16, 2008
    Report Date
    September 30, 2008
    Manufacturer
    LIFESCAN, INC.
    Product Code
    NBW
    PMA / PMN Number
    NA
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    LAY USER/PATIENT

    Narratives

    Additional Manufacturer Narrative · 1

    LIFESCAN HAS REQUESTED THE RETURN OF THE SUBJECT LFS PROD FOR VAL, BUT HAS NOT YET REC'D THEM. IF THE LFS PROD IS RETURNED, LIFESCAN WILL EVALUATE THEM AND IF THE LFS PROD DOES NOT PASS INSPECTION, LIFESCAN WILL INFORM FDA OF THE RESULTS IN A SUPPLEMENTAL REPORT.

    Description of Event or Problem · 1

    ON SEPTEMBER 30, 2008, THE LAY-USER/PT CONTACTED INT'L AFFILIATE, ALLEGING THAT THE ONETOUCH ULTRASMART METER HAS A POWER ISSUE (CALCODE FROZEN).THE PT CLAIMED THAT THE POWER ISSUE FIRST OCCURRED IN 2008 IMMEDIATELY BEFORE HE STARTED TO HAVE HIGH SYMPTOMS DESCRIBED AS "FRUSTRATED AND SHORT TEMPERED". THE DURATION OF THE HIGH SYMPTOMS WAS A FEW DAYS. THE PT TRIED TO SUBSIDE THEM BY RESTING, RELAXING AND TRYING TO STAY IN A GOOD MOOD. THE PT ALSO CONTINUED TAKING HIS MEDICATION AS PRESCRIBED UNTIL HE WENT TO THE DR. A FEW DAYS LATER, AND HAD HIS MEDICATIONS INCREASED. THE PT WENT TO SEE THE DR TWO DAYS AFTER THE REPORTED ISSUE BEGAN. BASED ON THE HIGH READINGS OBTAINED ON THE DR'S METER (UNSPECIFIED NUMERIC NUMBER), THE DR INCREASED THE PT'S ORAL DIABETES MEDICATION. AFTER THE PT WAS TAKING THE INCREASED DOSE OF HIS ORAL DIABETES MEDICATIONS AS PRESCRIBED BY THE DR, SHE STARTED TO EXPERIENCE LOW SYMPTOMS DESCRIBED AS "DIZZINESS, NAUSEA, CHILLS, SHAKING, AND CRAVING FOR FOOD/SUGAR". PRIOR TO THE AFOREMENTIONED SYMPTOMS, HE WAS PERFORMING PHYSICAL ACTIVITY AND ATE AS NORMAL PRIOR TO EXPERIENCING THE LOW SYMPTOMS. THE PT HAD BEEN TAKING THE ADDED ACTOS IN THE MORNING AS WELL AS IN THE EVENING. ON THE TWO OCCASIONS, HE EXPERIENCED THE LOW SYMPTOMS. ONE DAY HE WOKE UP IN THE NIGHT, AND THE OTHER DAY HE EXPERIENCED THE ALLEGED LOW SYMPTOMS BEFORE GOING TO BED. THE DURATION OF THE ALLEGED LOW SYMPTOMS LASTED APPROX 20-30 MINS. AFTER THE PT ALLEGEDLY ATE SOMETHING, THE SYMPTOMS ABATED. THE PT REPORTEDLY HAD NOT BEEN TESTING HIS GLUCOSE FOR A FEW DAYS LEADING UP TO THE LOW SYMPTOMS DUE TO THE POWER ISSUE. THE PT BELIEVES THAT HE HAD BEEN ABLE TO OBTAIN HIS BLOOD GLUCOSE READINGS PRIOR TO THE ALLEGED HYPERGLYCEMIA AND HYPOGLYCEMIA EPISODES, HE COULD HAVE PREVENTED THE AFOREMENTIONED SYMPTOM. DURING TROUBLESHOOTING, THE CUSTOMER CARE ADVOCATE VERIFIED THAT THE SUBJECT METER IS NOT NEW, THERE WAS NO PROD MISUSE AND THE METER TURNS OFF WHEN THE POWER BUTTON IS PRESSED. HOWEVER, THE SUBJECT METER FREEZES ON THE FASTFACTS SCREEN WHEN THE "I BUTTON" IS PRESSED. THIS COMPLAINT IS BEING REPORTED BECAUSE THE PT CLAIMED HE HAD SYMPTOMS THAT WAS SUGGESTIVE OF HYPERGLYCEMIA AND HYPOGLYCEMIA AFTER HE WAS NOT ABLE TO TEST HER BLOOD GLUCOSE DUE TO THE REPORTED ISSUE. REPLACEMENT PRODS WERE SENT TO THE PT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ONE TOUCH ULTRASMART METER GLUCOSE MONITORING SYS/KIT NBW LIFESCAN, INC. NA 2789510

    Patients

    Seq Age Sex Outcome Treatment
    1 58 YR Life Threatening| R