BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ONE TOUCH ULTRAMINI METER

    MDR report key: 1060356 · Received June 17, 2008

    Report

    Report Number
    2939301-2008-01068
    Event Type
    Injury
    Date Received
    June 17, 2008
    Date of Event
    May 30, 2008
    Report Date
    May 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
    MD, US
    Reporter Occupation
    LAY USER/PATIENT

    Narratives

    Additional Manufacturer Narrative · 1

    LIFESCAN HAS REQUESTED THE RETURN OF THE SUBJECT PRODUCT FOR EVAL, BUT HAS NOT YET RECEIVED IT. IF THE PRODUCT 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/REPORTER CALLED LIFESCAN (LFS) IN 2008 ON BEHALF OF THE LAY USER/PT AND ALLEGED THAT A ONE TOUCH ULTRAMINI METER WAS SHOWING PREVIOUS READINGS WHEN SHE WAS TRYING TO PERFORM A BLOOD SUGAR TEST. THE MEDICAL AFFAIRS SPECIALIST SPOKE WITH THE PT AND VERIFIED THE FOLLOWING INFO. THE PT'S SON MENTIONED THAT THE PT HAD BOUGHT THE REPORTED METER TWO TO THREE WEEKS BEFORE HE CALLED LFS AND REPORTEDLY COULD NOT USE IT REGULARLY ON A BACK-UP METER DURING THE ISSUE, BUT THAT METER WOULD NOT WORK SOMETIMES. SHE WAS REPORTEDLY TAKING REGULAR AMOUNT OF INSULIN DURING THE ISSUE. ON THE SAME DAY AT AROUND 6:00PM, THE PT WAS REPORTEDLY FEELING SWEATY. HER BLOOD SUGAR WAS TESTED ON A BACK-UP METER AND OBTAINED A READING OF 65 MG/DL. SHE ATE AND DRANK SOMETHING AND FELT BETTER. THE PT WAS UNABLE TO RECALL WHETHER SHE WAS ABLE TO TEST HER BLOOD SUGAR THAT DAY PRIOR TO DEVELOPING THE SYMPTOMS OR NOT. THE CUSTOMER SERVICE AGENT (CSA) WAS ABLE TO RESOLVE THE ISSUE BY TRAINING DURING TROUBLESHOOTING. REPLACEMENT PRODUCTS HAVE BEEN SENT TO THE PT. THIS COMPLAINT IS BEING REPORTED AS AN ADVERSE EVENT, AS THE PT REPORTEDLY DEVELOPED A SYMPTOM INDICATIVE OF HYPOGLYCEMIA AND HAD TO ADMINISTER FOOD AND BEVERAGE TO TREAT HER SYMPTOMS AFTER THE REPORTED ISSUE STARTED. IT IS UNK WHETHER SHE WAS ABLE TO TEST HER BLOOD SUGAR ON THE DAY OF THE EVENT PRIOR TO DEVELOPING THE SYMPTOMS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ONE TOUCH ULTRAMINI METER GLUCOSE MONITORING SYS/KIT NBW LIFESCAN, INC. NA 2813143

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Life Threatening| R