BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ONE TOUCH ULTRAMINI METER

    MDR report key: 1242232 · Received November 19, 2008

    Report

    Report Number
    2939301-2008-03190
    Event Type
    Injury
    Date Received
    November 19, 2008
    Report Date
    November 7, 2008
    Manufacturer
    LIFESCAN, INC.
    Product Code
    NBW
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MO, US
    Reporter Occupation
    LAY USER/PATIENT

    Narratives

    Additional Manufacturer Narrative · 1

    LIFESCAN (LFS) HAS REQUESTED RETURN OF THE SUBJECT PRODUCT(S) FOR EVALUATION. IF THE PRODUCT(S) ARE RETURNED, LFS WILL EVALUATE IT/THEM AND INFORM FDA OF PRODUCT(S) THAT DO NOT PASS INSPECTION IN A SUPPLEMENTAL REPORT.

    Description of Event or Problem · 1

    IN 2008, THE LAY USER/PATIENT CONTACTED LIFESCAN (LFS) ALLEGING THAT SHE HAS HAD PROBLEMS (UNSPECIFIED ISSUES) WITH HER ONETOUCH ULTRAMINI METER SINCE SHE RECEIVED IT FIVE MONTHS EARLIER, AND SO SHE WAS NOT TESTING. IT IS UNKNOWN HOW OFTEN THE PATIENT WAS SUPPOSED TO TEST ON HER METER. THE PATIENT STATED SHE TAKES A DAILY DOSE OF 1000 MG GLUCOPHAGE BUT IT IS UNKNOWN IF THE PATIENT CONTINUED THIS REGIMEN AFTER SHE STOPPED TESTING. ON THAT MONTH (AFTER THE ISSUE FIRST OCCURRED), SHE BECAME SWEATY, WEAK AND NAUSEATED. INFORMATION REGARDING THE EVENTS LEADING TO HER SYMPTOMS, SUCH AS MEDICATIONS, ACTIVITY LEVELS, AND FOOD INTAKE WERE NOT PROVIDED. IT WAS NOTED THAT SHE HAD MORE FOOD/DRINK BUT ITS UNCLEAR IF THIS ACTION WAS TAKEN BEFORE OR AFTER SHE HAD DEVELOPED HER REPORTED SYMPTOMS. SHE ALSO CLAIMED THAT SHE RECEIVED TREATMENT AT THE EMERGENCY ROOM ON AN UNSPECIFIED DATE/TIME AS A RESULT OF HER METER ISSUES. HER BLOOD GLUCOSE WAS "68 MG/DL" ON THE HOSPITAL'S DEVICE AND SHE WAS TREATED WITH IV FLUIDS (UNKNOWN MEDICATIONS). THE CUSTOMER CARE ADVOCATE (CCA) ALSO NOTED THAT AN "ERROR 1" MESSAGE APPEARED AFTER THE PATIENT REPLACED THE BATTERY. IT WAS NOT SPECIFIED WHEN THE ERROR MESSAGE FIRST OCCURRED. ACCORDING TO THE CCA DOCUMENTATION, THE ERROR MESSAGE WAS NOT RESOLVED WITH TROUBLESHOOTING. THE MEDICAL AFFAIRS SPECIALIST WAS UNABLE TO CONTACT THE PATIENT FOR ADDITIONAL INFORMATION; THEREFORE, THIS COMPLAINT IS BEING CLASSIFIED BASED ON THE CUSTOMER CARE ADVOCATE'S DOCUMENTATION. THIS COMPLAINT IS BEING REPORTED BECAUSE THE PATIENT ALLEGEDLY DEVELOPED SYMPTOMS SUGGESTIVE OF HYPOGLYCEMIA AFTER NOT BEING ABLE TO TEST WITH HER METER. IN ADDITION, THE ERROR MESSAGE WAS UNRESOLVED WITH TROUBLESHOOTING.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 58 YR Hospitalization| L| R