BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ONE TOUCH II METER

    MDR report key: 1020927 · Received March 27, 2008

    Report

    Report Number
    2939301-2008-00411
    Event Type
    Injury
    Date Received
    March 27, 2008
    Date of Event
    May 2, 2007
    Report Date
    March 7, 2008
    Manufacturer
    LIFESCAN, INC.
    Product Code
    NBW
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OK, US
    Reporter Occupation
    LAY USER/PATIENT

    Narratives

    Additional Manufacturer Narrative · 1

    LIFESCAN HAS REQUESTED THE RETURN OF THE SUBJECT METER AND STRIPS FOR EVALUATION, BUT HAS NOT YET RECEIVED THEM. IF EITHER THE METER OR STRIPS ARE RETURNED, LIFESCAN WILL EVALUATE THEM AND, IF EITHER THE METER OR STRIPS DO NOT PASS INSPECTION, LIFESCAN WILL INFORM FDA OF THE RESULTS IN THE SUPPLEMENTAL REPORT.

    Description of Event or Problem · 1

    IN 2008, THE REPORTER/PATIENT'S DAUGHTER CONTACTED LIFESCAN ON BEHALF OF THE LAY USER/PATIENT ALLEGING A POWER ISSUE (DOES NOT TURN ON) WITH THE PATIENT'S ONE TOUCH II METER. THE MEDICAL AFFAIRS SPECIALIST WAS UNABLE TO CONTACT THE REPORTER FOR ADDITIONAL INFORMATION. THE FOLLOWING INFORMATION WAS OBTAINED FROM THE CUSTOMER CARE ADVOCATE'S DOCUMENTATION. THE REPORTER WAS UNABLE TO REPORT WHEN THE POWER ISSUE STARTED BUT CLAIMED THAT THE PATIENT WAS ADMITTED TO THE HOSPITAL IN 2007. THE PATIENT REPORTEDLY DEVELOPED SYMPTOMS OF FEELING THIRSTY AND "OTHER SYMPTOMS" AT AN UNSPECIFIED TIME AFTER THE POWER ISSUE BEGAN. THE REPORTER STATED THAT THE PATIENT'S BLOOD GLUCOSE WAS "500 MG/DL" ON THE HOSPITAL METER BUT SHE WAS UNABLE TO SPECIFY WHAT TYPE OF TREATMENT THE PATIENT RECEIVED AT THE HOSPITAL. THE CUSTOMER CARE ADVOCATE (CCA) WENT THROUGH TROUBLESHOOTING WITH THE REPORTER AND NOTED THAT THE BATTERY WAS NOT REPLACED PER THE OWNER'S MANUAL. THE REPORTER DID NOT HAVE A REPLACEMENT BATTERY, SO THE POWER ISSUE WAS NOT RESOLVED. REPLACEMENT PRODUCTS WERE SENT TO THE PATIENT. IT WOULD BE HELPFUL TO KNOW WHEN THE POWER ISSUE STARTED, HOW OFTEN THE PATIENT TESTS, WHAT DIABETES MEDICATIONS, IF ANY, THE PATIENT TAKES, AND IF SHE MADE ANY CHANGES TO HER DIABETES CARE REGIMEN AS A RESULT OF THE POWER ISSUE. IT WOULD ALSO BE HELPFUL TO KNOW IF THE PATIENT HAD ANY OTHER MEANS OF TESTING HER BLOOD GLUCOSE LEVELS BEFORE SHE WAS ADMITTED TO THE HOSPITAL. BASED ON THE PROVIDED INFORMATION, THIS COMPLAINT IS BEING REPORTED BECAUSE THE PATIENT ALLEGEDLY WAS TREATED FOR HYPERGLYCEMIA WITH A BLOOD GLUCOSE OF 500 MG/DL AFTER THE POWER ISSUE BEGAN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ONE TOUCH II METER GLUCOSE MONITORING SYS/KIT NBW LIFESCAN, INC. NA 216391A

    Patients

    Seq Age Sex Outcome Treatment
    1 79 YR Hospitalization| L