BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ONE TOUCH ULTRA METER

    MDR report key: 1092823 · Received July 31, 2008

    Report

    Report Number
    2939301-2008-01613
    Event Type
    Injury
    Date Received
    July 31, 2008
    Report Date
    July 28, 2008
    Manufacturer
    LIFESCAN, INC.
    Product Code
    NBW
    PMA / PMN Number
    NA
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER

    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/PATIENT CONTACTED LIFESCAN (LFS) ALLEGING THAT A ONE TOUCH ULTRA METER HAD AN APPLY SAMPLE ISSUE. THE COMPLAINT WAS BASED ON THE CUSTOMER SERVICE REPRESENTATIVE'S (CSR) DOCUMENTATION. THE PATIENT MENTIONED THAT THE ISSUE WITH THE LFS PRODUCT FIRST OCCURRED TWO DAYS PRIOR, WHEN AN "APPLY SAMPLE" MESSAGE APPEARED ON HER METER. AS A RESULT OF THE ALLEGED METER ISSUE, THE PATIENT REPORTEDLY DID NOT MAKE ANY CHANGES TOWARDS HER DIABETES MANAGEMENT. THE PATIENT TESTS HER BLOOD GLUCOSE THREE TIMES A DAY AND MANAGES HER DIABETES WITH PILLS, DIET AND EXERCISE. THE PATIENT REPORTEDLY BECAME SHAKY SOMETIME AFTER THE ALLEGED METER ISSUE BEGAN. IT WAS UNKNOWN WHETHER THE PATIENT PERFORMED SELF-TREATMENT BASED ON HER REPORTED SYMPTOMS. TWO DAYS LATER, AT 3:10 PM, THE PATIENT REPORTEDLY VISITED HER HEALTHCARE PROCESSIONAL (HCP) FOR AN UNSPECIFIED REASON AND REPORTEDLY DID NOT RECEIVE ANY MEDICAL TREATMENTS. THIS WAS NOT A NEW OUT OF BOX PRODUCT. THE SAMPLE APPLICATION THE PATIENT PERFORMED TO TEST HER BLOOD SUGAR WAS INCORRECT. WHEN A RETEST WAS PERFORMED WITH A NEW TEST STRIP, THE ISSUE WAS RESOLVED. ALTHOUGH THE ALLEGED METER ISSUE WAS RESOLVED THROUGH TROUBLESHOOTING, THIS COMPLAINT IS BEING REPORTED BECAUSE THE PATIENT REPORTEDLY DEVELOPED SYMPTOMS SUGGESTIVE OF HYPOGLYCEMIA AFTER THE ALLEGED METER ISSUE BEGAN. THE PATIENT'S PRODUCTS HAVE BEEN REPLACED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ONE TOUCH ULTRA METER GLUCOSE MONITORING SYS/KIT NBW LIFESCAN, INC. NA 2832529

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Life Threatening| R