BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ONETOUCH BASIC ENHANCED METER

    MDR report key: 1092307 · Received August 1, 2008

    Report

    Report Number
    2939301-2008-01646
    Event Type
    Injury
    Date Received
    August 1, 2008
    Report Date
    July 23, 2008
    Manufacturer
    LIFESCAN, INC.
    Product Code
    NBW
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NJ, 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 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'S NIECE CONTACTED LIFESCAN (LFS) ALLEGING THAT THE PT'S ONETOUCH BASIC ENHANCED METER'S DISPLAY WAS MISSING SEGMENTS. THE MEDICAL AFFAIRS SPECIALIST (MAS) SPOKE WITH THE PT ON JULY 30, 2008 AND OBTAINED THE FOLLOWING INFO. THE PT REPORTED THAT THE ALLEGED ISSUE BEGAN APPROX 1 MONTH PRIOR TO CONTACTING LFS. AS A RESULT OF THE ISSUE, THE PT CLAIMED SHE DISCONTINUED TESTING HER BLOOD GLUCOSE, BUT REPORTEDLY TOOK HER USUAL DAILY DOSE OF GLUCOPHAGE (2 PILLS A DAY, 500MG/PILL). IN ADDITION, THE PT MENTIONED SHE WOULD TAKE "16/20 INSULIN" WHEN SHE FELT HER BLOOD GLUCOSE WAS "HIGH." SOMETIME AFTER THE REPORTED ISSUE BEGAN (DATE/TIME UNK), THE PT REPORTED DEVELOPING A "SEVERE HEADACHE AND INCREASED VISION LOSS." THE PT CLAIMED SHE WENT TO THE EMERGENCY ROOM SOMETIME IN JULY (DATE UNK) AS A RESULT OF HER ASTHMA AND BLOOD GLUCOSE RUNNING HIGH. SHE MENTIONED WHEN SHE ARRIVED TO THE ER, SHE WAS TESTED WITH A HOSPITAL METER AND THEY OBTAINED A READING OF "600 MG/DL" AND WAS TREATED WITH INSULIN. THE PT FURTHER REPORTED SHE WAS ADMITTED INTO THE HOSPITAL FOR 4 DAYS FOR HER ASTHMA AND HYPERGLYCEMIA. AT THE TIME OF TROUBLESHOOTING, THE CUSTOMER CARE ADVOCATE (CCA) WAS UNABLE TO RESOLVE THE ISSUE. REPLACEMENT PRODUCTS 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 WAS TREATED FOR HYPERGLYCEMIA BY AN HEALTH CARE PROFESSIONAL AFTER THE ALLEGED METER ISSUE BEGAN.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| L| R