BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ONE TOUCH ULTRAMINI METER

    MDR report key: 1060360 · Received June 17, 2008

    Report

    Report Number
    2939301-2008-01065
    Event Type
    Injury
    Date Received
    June 17, 2008
    Report Date
    May 21, 2008
    Manufacturer
    LIFESCAN, INC.
    Product Code
    NBW
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, 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 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 ALLEGING THE ONE TOUCH ULTRA MINI METER WAS READING INACCURATELY LOW. THE MEDICAL AFFAIRS SPECIALIST WAS NOT ABLE TO CONTACT THE PT TO ASK FOLLOW UP QUESTIONS. THE PT STATED THAT SOMETIME AT THE END OF THE PREVIOUS MONTH, HE OBTAINED A 194 MG/DL READING ON HIS METER AND A 240 MG/DL READING ON ANOTHER METER. BASED ON STATISTICAL METHODOLOGY, THE CALCULATED DIFFERENCE OF THESE GLUCOSE RESULTS EXCEEDS THE EXPECTED VALUE OF <= 30%. HE DECREASED HIS INSULIN DOSE BY 20 UNITS BASED ON THE READING AND FELT SYMPTOMS OF LETHARGY, NO ENERGY, SHAKING, AND DROWSINESS SOMETIME AFTER THE ISSUE BEGAN. THE PT DID NOT MENTION SEEKING MEDICAL ATTENTION. IT WAS DETERMINED DURING THE TROUBLESHOOTING TELEPHONE CALL, THE PATIENT'S TESTING TECHNIQUE WAS CORRECT BUT THE PT CLEANED THE PUNCTURE AREA INCORRECTLY. THE METER WAS SET TO THE CORRECT UNIT OF MEASURE. THE RESULTS WERE VERIFIED IN THE METER MEMORY. THIS COMPLAINT IS BEING REPORTED BECAUSE THE PT TOOK A DOSE OF INSULIN BASED ON HIS METER READING AND FELT SYMPTOMS SUGGESTIVE OF HYPOGLYCEMIA. ALTHOUGH THE PT TOOK A DECREASED DOSE OF INSULIN, IT IS NOT KNOWN WHETHER THAT DOSE IS STILL TOO HIGH BASED ON INACCURATE HIGH READINGS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ONE TOUCH ULTRAMINI METER GLUCOSE MONITORING SYS/KIT NBW LIFESCAN, INC. NA 2783259

    Patients

    Seq Age Sex Outcome Treatment
    1 43 YR Life Threatening