BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ONE TOUCH ULTRA METER

    MDR report key: 1173433 · Received September 23, 2008

    Report

    Report Number
    2939301-2008-02356
    Event Type
    Injury
    Date Received
    September 23, 2008
    Date of Event
    January 1, 2007
    Report Date
    September 12, 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 FOR EVAL, BUT HAS NOT YET RECEIVED IT. IF THE METER IS RETURNED, LIFESCAN WILL EVALUATE IT AND, IF THE METER DOES NOT PASS INSPECTION, LIFESCAN WILL INFORM FDA OF THE RESULTS IN A SUPPLEMENTAL REPORT. TEST STRIPS LOT NUMBER IS NO LONGER KNOWN BY THE PT.

    Description of Event or Problem · 1

    THIS SENIOR MEDICAL AFFAIRS SPECIALIST SPOKE WITH THE PT/LAYPERSON ON 9/17/08 IN RESPONSE TO HER 9/12/08 COMPLAINT TO A CUSTOMER CARE ADVOCATE, CCA. THE CCA REPLACED THE METER AND TEST STRIPS. THIS SPECIALIST HAS CLASSIFIED THE COMPLAINT BASED UPON THE INFO THE PT REPORTED TO HER ON 9/17/08. ON AND UNKNOWN DATE AND TIME IN 2007, THE PT REPORTEDLY OBTAINED 224 MG/DL ONE MORNING. BASED UPON THE RESULT, THE PT LOOKED HER REGULAR INSULIN ON A SLIDING SCALE, ATE BREAKFAST, AND WENT TO WORK. AROUND NOON THE PT ATE LUNCH BUT DID NOT TEST OR TAKE INSULIN. AROUND 2 P.M., THE PT "PASSED OUT". COLLEAGUES CALLED EMT WHO POSSIBLY TESTED ON THEIR METER, RESULT NOT RECALLED, AND GAVE HER IV GLUCOSE. THE PT WAS NOT HOSPITALIZED. THE PT ALLEGED THAT THE RESULT IN THE MORNING WAS INACCURATELY ELEVATED, RESULTING IN ADMINISTERING EXTRA INSULIN FOLLOWED BY HYPOGLYCEMIA. REPORTEDLY, THE PT CONTINUED USING THE METER WITHOUT INCIDENT. BECAUSE THE PT ALLEGED THAT SHE WAS TREATED FOR HYPOGLYCEMIA DUE TO AN ACCURATE RESULT ON HER METER, THE COMPLAINT IS CLASSIFIED AS AN ADVERSE EVENT.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 38 YR Life Threatening| R