BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ONE TOUCH ULTRA2 METER

    MDR report key: 1173424 · Received September 23, 2008

    Report

    Report Number
    2939301-2008-02365
    Event Type
    Injury
    Date Received
    September 23, 2008
    Date of Event
    September 5, 2008
    Report Date
    September 18, 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 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/PT CONTACTED LIFESCAN (LFS) ALLEGING THAT HIS ONE TOUCH ULTRA2 METER WAS READING INACCURATELY LOW. THE MEDICAL AFFAIRS SPECIALIST (MAS) SPOKE WITH THE PT ON THE NEXT DAY, AND OBTAINED THE FOLLOWING INFO. THE PT REPORTED THAT THE SUBJECT METER PROVIDED AN ALLEGED HIGH REDING (AND NOT LOW AS DOCUMENTED) ON THE MORNING OF THE EVENT DATE. AT 8:30 AM, THE PT REPORTED OBTAINING A RESULT OF "140 MG/DL" ON THE SUBJECT METER. THE PATIENT'S SPOUSE THEN ADMINISTERED AN UNSPECIFIED AMOUNT OF NOVOLIN (BASED ON A SLIDING SCALE) AND 25 UNITS OF LANTUS INSULIN. APPROXIMATELY 2-3 HOURS AFTER TAKING THE INSULIN, THE PT CLAIMED HE STARTED TO FEEL FATIGUED, NAUSEOUS, AND BEGAN TO SWEAT PROFUSELY. HIS WIFE IMMEDIATELY GAVE HIM SOME ORANGE JUICE WITH ADDED SUGAR, BUT WHEN HIS SYMPTOMS DID NOT GET BETTER SHE CONTACTED EMERGENCY SERVICES. THE PT REPORTED THAT HIS BLOOD GLUCOSE WAS TESTED WITH THE EMT'S METER BUT HE COULD NOT RECALL THE RESULT. WHEN TAKEN TO THE EMERGENCY ROOM, THEY OBTAINED A READING OF "40 MG/DL" ON AN ER METER AND THE PT WAS REPORTEDLY TREATED WITH IV GLUCOSE. THE PT STATED HE WAS ADMITTED INTO THE HOSPITAL FOR 3 DAYS TO "REGULATE HIS BLOOD SUGAR." AT THAT TIME OF TROUBLESHOOTING, THE CUSTOMER CARE ADVOCATE (CCA) CONFIRMED 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 HE OBTAINED AN INACCURATE HIGH READING ON THE SUBJECT METER, ADMINISTERED TREATMENT BASED ON THE ALLEGED READING AND REPORTEDLY WAS TREATED BY AN HCP FOR SEVERE HYPOGLYCEMIA AFTER THE ALLEGED METER ISSUE BEGAN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ONE TOUCH ULTRA2 METER GLUCOSE MONITORING SYS/KIT NBW LIFESCAN, INC. NA 2750423

    Patients

    Seq Age Sex Outcome Treatment
    1 65 YR Hospitalization| L| R