BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ONE TOUCH ULTRA2 METER

    MDR report key: 1181629 · Received October 15, 2008

    Report

    Report Number
    2939301-2008-02447
    Event Type
    Injury
    Date Received
    October 15, 2008
    Date of Event
    September 22, 2008
    Report Date
    September 23, 2008
    Manufacturer
    LIFESCAN, INC.
    Product Code
    NBW
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    LAY USER/PATIENT

    Narratives

    Additional Manufacturer Narrative · 1

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

    THE LAY USER/PT'S DAUGHTER CONTACTED LIFESCAN (LFS) IN 2008 AND ALLEGED THAT THE PT'S ONETOUCH ULTRA2 METER WAS DISPLAYING ERROR 3 MESSAGE. THE MEDICAL AFFAIRS SPECIALIST (MAS) CALLED AND SPOKE WITH THE DAUGHTER ON SEPT. 26, 2008 AND OBTAINED ADDITIONAL INFO. THE DAUGHTER REPORTED THAT THE ALLEGED ISSUE FIRST OCCURRED ON APPROX FIVE MONTHS EARLIER. SHE INFORMED THE MAS THAT SINCE THAT DAY, THE PT HAD NOT TESTED HER BLOOD GLUCOSE SINCE THE "METER WAS NOT WORKING". SHE HAD CONTINUED TO TAKE HER DIABETES ORAL MEDICATION (NAME NOT PROVIDED, DOSAGE=2 PILLS ONCE/DAILY) DURING THE TIME SHE WAS NOT ABLE TO TEST HER BLOOD GLUCOSE. ON (1 DAY PRIOR TO CALLING LFS), THE PT REPORTEDLY STARTED EXPERIENCING SYMPTOMS OF BEING WEAK, UNABLE TO WALK, AND HAVING FREQUENT URINATION. SHE ATTEMPTED TO TEST ON THE SUBJECT METER, BUT RECEIVED THE ERROR 3 MESSAGE. THE DAUGHTER THEN MADE AN APPOINTMENT FOR SAME DAY WITH THE PT'S DOCTOR AND SHE WAS TESTED ON THE DOCTOR'S METER WITH A RESULT OF 277 MG/DL. THE PT WAS NOT ADMINISTERED ANY TREATMENT, BUT WAS GIVEN A NEW DIET PLAN AND HER ORAL DIABETES MEDICATION FREQUENCY WAS INCREASED TO 2 PILLS TWICE/DAILY. AT THE TIME OF TROUBLESHOOTING, IT WAS VERIFIED THAT THIS WAS NOT A NEW PRODUCT. THE PT'S TESTING TECHNIQUE WAS REVIEWED TO BE INCORRECT (USE ERROR). THE ALLEGED ISSUE WAS RESOLVED WHEN A RETEST WAS PERFORMED. THIS COMPLAINT IS BEING REPORTED BECAUSE THE DAUGHTER CLAIMED THAT THE PT WAS NOT ABLE TO TEST ON THE METER FOR ABOUT 4 MONTHS AND LATER ALLEGEDLY EXPERIENCED SYMPTOMS SUGGESTIVE OF HYPERGLYCEMIA. THE DOCTOR REPORTEDLY INCREASED THE PT'S ORAL MEDICATION FREQUENCY DURING MEDICAL APPOINTMENT. THE ALLEGED ISSUE WAS RESOLVED WITH TROUBLESHOOTING (USE ERROR WAS INVOLVED). REPLACEMENT PRODUCTS WERE SENT TO THE LAY USER/PT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ONE TOUCH ULTRA2 METER GLUCOSE MONITORING SYS/KIT NBW LIFESCAN, INC. NA 2775059

    Patients

    Seq Age Sex Outcome Treatment
    1 75 YR Life Threatening