BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ONE TOUCH ULTRA METER

    MDR report key: 1192398 · Received October 15, 2008

    Report

    Report Number
    2939301-2008-02544
    Event Type
    Injury
    Date Received
    October 15, 2008
    Date of Event
    September 1, 2008
    Report Date
    September 29, 2008
    Manufacturer
    LIFESCAN, INC.
    Product Code
    NBW
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, 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

    THE LAY USER/PATIENT CONTACTED LIFESCAN IN 2008 AND ALLEGED THAT HER ONE TOUCH ULTRA METER WAS READING INACCURATELY ERRATIC. THE MEDICAL AFFAIRS SPECIALIST WAS UNABLE TO REACH THE PATIENT AFTER SEVERAL ATTEMPTS VIA PHONE. A LETTER WAS SENT TO THE ADDRESS PROVIDED. THE PATIENT REPORTED THAT THE ALLEGED ISSUE FIRST OCCURRED ON THE SAME DAY. SHE REPORTED OBTAINING RESULTS OF 120 MG/DL, AND 156 MG/DL (HOWEVER, METER'S MEMORY CONFIRMED THAT THE ACTUAL RESULTS WERE 197, 194, 216, AND 165 MG/DL), PERFORMED GREATER THAN 20 MINUTES APART. AS A RESULT OF THE REPORTED ISSUE, THE PATIENT SKIPPED A DOSE OF HER INSULIN (LANTUS 45 UNITS). SHE ALSO REPORTED THAT SHE EXPERIENCED SYMPTOMS OF BEING SWEATY, SHAKY, AND LIGHTHEADED AFTER THE REPORTED ISSUE BEGAN. SHE DID NOT RECEIVE ANY MEDICAL INTERVENTION AND WAS NOT TESTED ON ANY OTHER DEVICE. AT THE TIME OF TROUBLESHOOTING, IT WAS VERIFIED THAT THE METER WAS SET IN THE RIGHT UNIT OF MEASUREMENT (MG/DL). IT WAS DETERMINED THAT THE PATIENT'S TESTING TECHNIQUE WAS INCORRECT (USE ERROR), BUT SHE WAS CLEANING THE PUNCTURE AREA PROPERLY. THIS COMPLAINT IS BEING REPORTED BECAUSE THE PATIENT CLAIMED THAT SHE EXPERIENCED SYMPTOMS SUGGESTIVE OF HYPOGLYCEMIA AFTER THE REPORTED ISSUE BEGAN. SHE REPORTEDLY ALTERED HER INSULIN REGIMEN DUE TO THE ISSUE. THE PATIENT DID NOT RECEIVE ANY MEDICAL INTERVENTION. REPLACEMENT PRODUCTS WERE SENT TO THE LAY USER/PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ONE TOUCH ULTRA METER GLUCOSE MONITORING SYS/KIT NBW LIFESCAN, INC. NA 2828416

    Patients

    Seq Age Sex Outcome Treatment
    1 51 YR Life Threatening