BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ONE TOUCH ULTRASMART METER

    MDR report key: 1567620 · Received December 22, 2009

    Report

    Report Number
    2939301-2009-07978
    Event Type
    Injury
    Date Received
    December 22, 2009
    Date of Event
    December 15, 2009
    Report Date
    December 15, 2009
    Manufacturer
    LIFESCAN, INC.
    Product Code
    NBW
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN, 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

    THE MEDICAL SURVEILLANCE SPECIALIST (MSS) CLASSIFIED THIS COMPLAINT BASED ON CUSTOMER SERVICE REPRESENTATIVE (CSR) DOCUMENTATION. THE LAY USER/PATIENT CONTACTED LIFESCAN (LFS) CUSTOMER SERVICE IN 2009 ALLEGING THAT HIS ONETOUCH ULTRASMART METER STARTED TO GIVE HIM INACCURATE ERRATIC METER READINGS. HE REPORTEDLY OBTAINED BLOOD GLUCOSE RESULTS OF "183, 148, AND 127 MG/DL" ON THE SUBJECT METER WITHIN A 20 MINUTE TIME PERIOD. BASED ON STATISTICAL METHODOLOGY, THE CALCULATED DIFFERENCE OF THESE RESULTS EXCEED THE EXPECTED VALUE OF <=20%. IT WAS NOTED THAT THE PATIENT DID NOT TAKE ANY ACTIONS IN REGARDS TO HIS DIABETES MANAGEMENT AFTER THE REPORTED ISSUE OCCURRED. HE CLAIMED THAT 5-10 MINUTES AFTER THE REPORTED ISSUE OCCURRED, HE BECAME SHAKY AND NERVOUS, SO HE DRANK ORANGE JUICE, WHICH IS WHAT HE NORMALLY DOES WHEN HE HAS LOW BLOOD GLUCOSE LEVELS. NO OTHER FORMS OF TREATMENT WERE REPORTED. ACCORDING TO THE TROUBLESHOOTING PERFORMED BY CUSTOMER SERVICE, THE CORRECT TESTING STEPS WERE TAKEN. THE CSR ATTEMPTED TO WALK THE PATIENT THROUGH A CONTROL SOLUTION TEST BUT THE PATIENT DID NOT HAVE THE APPROPRIATE TESTING SUPPLIES AT THE TIME OF THE CALL. THIS COMPLAINT IS BEING REPORTED BECAUSE THE PATIENT CLAIMED, HE BECAME HYPOGLYCEMIC AFTER OBTAINING ALLEGED INACCURATE METER READINGS. REPLACEMENT PRODUCTS WERE SENT TO THE PATIENT.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 63 YR Life Threatening| R