BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ONE TOUCH ULTRASMART METER

    MDR report key: 1060364 · Received June 17, 2008

    Report

    Report Number
    2939301-2008-01060
    Event Type
    Injury
    Date Received
    June 17, 2008
    Date of Event
    May 28, 2008
    Report Date
    May 28, 2008
    Manufacturer
    LIFESCAN, INC.
    Product Code
    NBW
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AL, 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/PATIENT CONTACTED LIFESCAN (LFS) ALLEGING HER ONE TOUCH ULTRASMART METER WAS READING INACCURATE HIGH. THE MEDICAL AFFAIRS SPECIALIST (MAS) SPOKE WITH THE PT ON 06/11/08 AND OBTAINED THE FOLLOWING INFO. THE PT REPORTED THAT THE ALLEGED ISSUE STARTED APPROXIMATELY THE EVENING PRIOR TO CONTACTING LFS. ON THE DAY PRIOR TO ORIGINAL DATE AT 11:30PM, THE PT TESTED ON THE SUBJECT METER AND OBTAINED A READING OF "237 OR 289 MG/DL." ALTHOUGH THIS RESULT WAS REPORTEDLY HIGHER THAN HER USUAL READINGS OF "150-180 MG/DL" THE PATIENT DID NOT QUESTION THE RESULT AND REPORTEDLY ADMINISTERED 39 UNITS OF LEVEMIR INSULIN. THE PT CLAIMS SHE TAKEN 39 UNITS OF LEVEMIR AT BEDTIME IF HER BLOOD GLUCOSE IS GREATER THAN 175 MG/DL, 30 UNITS IF HER GLUCOSE IS BETWEEN 140 -160 MG/DL, AND SKIPS TAKING THE INSULIN IF HER BLOOD GLUCOSE IS BELOW 140 MG/DL. AT 2:30 AM ON ORIGINAL DATE, APPROXIMATELY THREE HOURS AFTER TAKING THE INSULIN, THE PT REPORTED WAKING UP TO "COLD SWEATS." THE PT CLAIMED SHE TESTED HER GLUCOSE ON THE SUBJECT METER AT THE TIME OF THE SYMPTOMS AND RECALLS OBTAINING A READING OF "79 MG/DL." THE PT PROCEEDED WITH TREATING SELF WITH A BEVERAGE AND ALSO A GLUCOSE TABLET. SHE CONFIRMED FEELING BETTER AFTER THE SELF-TREATMENT OF TROUBLESHOOTING, THE CCA CONFIRMED THAT THE SUBJECT METER WAS SET TO THE PROPER UNIT OF MEASURE SETTING (MG/DL), THAT THE PT WAS USING THE CORRECT TESTING TECHNIQUE, AND THAT THE PUNCTURE AREA WAS BEING CLEANED PROPERLY. REPLACEMENT PRODUCTS WERE SENT TO THE PT. THIS COMPLAINT IS BEING REPORTED BECAUSE THE PT CLAIMS SHE OBTAINED AN INACCURATE HIGH READING ON THE SUBJECT METER, ADMINISTERED TREATMENT BASED ON THE ALLEGED READING, AND REPORTEDLY DEVELOPED SYMPTOMS SUGGESTIVE OF SEVERE HYPOGLYCEMIA AFTER THE ALLEGED METER ISSUE BEGAN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ONE TOUCH ULTRASMART METER GLUCOSE MONITORING SYS/KIT NBW LIFESCAN, INC. NA 2766484

    Patients

    Seq Age Sex Outcome Treatment
    1 67 YR Life Threatening| R