BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ONE TOUCH ULTRAMINI METER

    MDR report key: 1060361 · Received June 17, 2008

    Report

    Report Number
    2939301-2008-01064
    Event Type
    Injury
    Date Received
    June 17, 2008
    Date of Event
    May 29, 2008
    Report Date
    May 30, 2008
    Manufacturer
    LIFESCAN, INC.
    Product Code
    NBW
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AL, 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/PATIENT CALLED LIFESCAN (LFS) IN 2008 AND ALLEGED THAT A ONE TOUCH ULTRAMINI METER WAS DISPLAYING "ERROR 1" MESSAGES. THE MEDICAL AFFAIRS SPECIALIST LISTENED TO THE RECORDED CALL AND OBTAINED THE FOLLOWING INFORMATION, AS THE PATIENT COULD NOT BE CONTACTED BY PHONE TO OBTAIN THE ADDITIONAL INFORMATION. IT IS UNKNOWN WHEN DID THE REPORTED ISSUE STARTED. ON NINE DAYS LATER AT AROUND 2:00 PM, AFTER THE REPORTED ISSUE, THE PATIENT HAD REPORTEDLY DEVELOPED LOW BLOOD SUGAR SYMPTOMS. IT IS UNKNOWN WHAT WERE THE EXACT SYMPTOMS THAT SHE WAS FEELING. SHE REPORTEDLY WAS AWARE THAT HER BLOOD SUGAR WAS LOW AND THEREFORE, SHE ATE SOMETHING SUGARY AND TESTED HER BLOOD SUGAR ON A BACK-UP METER AND RECEIVED A READING AROUND 88 MG/DL. IT IS UNKNOWN WHETHER THE PATIENT WAS TESTING HER BLOOD SUGAR ON THE BACK-UP METER PRIOR TO DEVELOPING THE REPORTED SYMPTOMS. REPLACEMENT PRODUCTS HAVE BEEN SENT TO THE PATIENT. THIS COMPLAINT IS BEING REPORTED AS AN ADVERSE EVENT, AS THE PATIENT ALLEGED THAT SHE WAS RECEIVING ERROR 1 MESSAGES ON THE REPORTED LFS METER AND LATER, DEVELOPED LOW BLOOD SUGAR SYMPTOMS AND PROVIDED SELF-TREATMENT. IT IS UNKNOWN WHETHER SHE WAS ABLE TO TEST HER BLOOD SUGAR AN THE BACK-UP METER PRIOR TO DEVELOPING THE SYMPTOMS OR NOT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ONE TOUCH ULTRAMINI METER GLUCOSE MONITORING SYS/KIT NBW LIFESCAN, INC. NA 2773080

    Patients

    Seq Age Sex Outcome Treatment
    1 63 YR Life Threatening| R