BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ONE TOUCH BASIC ENHANCED METER

    MDR report key: 1163078 · Received September 15, 2008

    Report

    Report Number
    2939301-2008-02245
    Event Type
    Injury
    Date Received
    September 15, 2008
    Report Date
    August 30, 2008
    Manufacturer
    LIFESCAN, INC.
    Product Code
    NBW
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, 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 REC'D 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

    IN 2008, THE LAY/USER PT CONTACTED LIFESCAN (LFS) ALLEGING THAT HER ONE TOUCH BASIC ENHANCED METER WOULD CONTINUOUSLY BEEP WHEN POWERED ON BUT THE METER'S DISPLAY REMAINED BLANK. THE COMPLAINT WAS CLASSIFIED BASED ON THE CUSTOMER CARE ADVOCATE (CCA) DOCUMENTATION, SINCE THE MEDICAL AFFAIRS SPECIALIST (MAS) WAS UNABLE TO REACH THE PT BY PHONE. THE PT ALLEGED THAT THE REPORTED ISSUE BEGAN ON THE MORNING OF FOUR DAYS EARLIER. SOMETIME AFTER THE ALLEGED ISSUE BEGAN (DATE/TIME UNK), THE PT CLAIMED SHE DEVELOPED THE SYMPTOM OF BLURRED VISION. THE PT DENIED TAKING ANY ACTION REGARDING HER DIABETES MGMT OR RECEIVING MEDICAL INTERVENTION AS A RESULT OF THE ISSUE. AT TIME OF TROUBLESHOOTING, THE CCA CONFIRMED THERE WAS NO KNOWN MISUSE TO THE SUBJECT METER. THE ISSUE REMAINED UNRESOLVED. PLACEMENT PRODS WERE SENT TO THE PT. THIS COMPLAINT IS BEING REPORTED BECAUSE THE PT CLAIMS SHE WAS UNABLE TO TEST HER BLOOD GLUCOSE DUE TO THE REPORTED ISSUE, AND REPORTEDLY DEVELOPED SYMPTOMS SUGGESTIVE OF HYPERGLYCEMIA AFTER THE ALLEGED METER ISSUE BEGAN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ONE TOUCH BASIC ENHANCED METER GLUCOSE MONITORING SYS/KIT NBW LIFESCAN, INC. NA 176230A

    Patients

    Seq Age Sex Outcome Treatment
    1 Life Threatening