BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ONE TOUCH ULTRA2 METER

    MDR report key: 1082199 · Received July 24, 2008

    Report

    Report Number
    2939301-2008-01504
    Event Type
    Injury
    Date Received
    July 24, 2008
    Date of Event
    July 22, 2008
    Report Date
    July 22, 2008
    Manufacturer
    LIFESCAN, INC.
    Product Code
    NBW
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MD, US
    Reporter Occupation
    LAY USER/PATIENT

    Narratives

    Additional Manufacturer Narrative · 1

    LIFESCAN HAS REQUESTED THE RETURN OF THE SUBJECT PRODUCTS FOR EVALUATION, BUT HAS NOT YET RECEIVED IT. IF THE PRODUCTS WILL BE RETURNED, LIFESCAN WILL EVALUATE IT AND, IF IT DOES NOT PASS INSPECTION, LIFESCAN WILL INFORM FDA OF THE RESULTS IN A SUPPLEMENTAL REPORT.

    Description of Event or Problem · 1

    THE LAY USER/PT CALLED LIFESCAN (LFS) IN 2008 AND ALLEGED THAT A ONE TOUCH ULTRA 2 METER WOULD NOT POWER ON. THE PT INDICATED THAT THE REPORTED ISSUE STARTED ON THE SAME DAY IN THE MORNING. ON THAT DAY AT AROUND 10:00 AM, THE PT WAS REPORTEDLY FEELING SHAKY. HE WAS UNABLE TO TEST HIS BLOOD SUGAR DUE TO THE REPORTED ISSUE. HE WAS AWARE THAT HIS BLOOD SUGAR WAS LOW AND THEREFORE, DRANK SOME ORANGE JUICE AND FELT BETTER. HE ALSO MENTIONED ABOUT RECEIVING ASSISTANCE AT THE HOSPITAL AFTER DRINKING ORANGE JUICE AND WAS TREATED WITH GLUCOSE. HE WAS UNABLE TO RECALL WHETHER HE WAS ABLE TO TEST HIS BLOOD SUGAR THAT DAY IN THE MORNING PRIOR TO DEVELOPING SHAKINESS OR NOT. HE MENTIONED THAT HE HAD TAKEN REGULAR AMOUNT OF LANTUS AND INSULIN R THAT DAY IN THE MORNING. HE STATED THAT HE PROBABLY HAD GUESSED DOSAGE OF INSULIN R, AS HE WAS UNABLE TO TEST HIS BLOOD SUGAR. HE WAS UNABLE TO RECALL HOW MUCH INSULIN R DID HE TAKE THAT MORNING PRIOR TO DEVELOPING SHAKINESS. THE CUSTOMER SERVICE AGENT (CSA) VERIFIED THAT THE PT WAS USING CORRECT TEST STRIPS, THE PT REPLACED THE BATTERY PER THE OWNER'S MANUAL, THE BATTERIES WERE INSTALLED CORRECTLY, THE CONDITION OF THE BATTERY CONTACTS WAS GOOD, THERE WAS NO MISUSE OF THE REPORTED PRODUCTS, AND THE PT DID NOT ATTEMPT TO DOWNLOAD THE METER RECENTLY. REPLACEMENT PRODUCTS HAVE BEEN SENT TO THE PT. THIS COMPLAINT IS BEING REPORTED AS AN ADVERSE EVENT, AS THE PT ALLEGEDLY DEVELOPED SYMPTOMS THAT COULD BE SUGGESTIVE OF HYPOGLYCEMIA AFTER THE REPORTED ISSUE STARTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ONE TOUCH ULTRA2 METER GLUCOSE MONITORING SYS/KIT NBW LIFESCAN, INC. NA 2827547

    Patients

    Seq Age Sex Outcome Treatment
    1 69 YR Life Threatening| R