BEUDAMED
    FDA Adverse Event Injury Summary report: N

    OT ULTRA METER

    MDR report key: 719741 · Received May 22, 2006

    Report

    Report Number
    2939301-2006-00732
    Event Type
    Injury
    Date Received
    May 22, 2006
    Report Date
    May 11, 2006
    Manufacturer
    LIFESCAN, INC.
    Product Code
    NBW
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NC, US
    Reporter Occupation
    PATIENT

    Narratives

    Description of Event or Problem · 1

    HER ONE TOUCH ULTRA METER WS READING INACCURATELY LOW. THE MEDICAL AFFAIRS SPECIALIST MAILED A LETTER TO THE PATIENT ON MAY 16,2006 SINCE SHE COULD NOT BE REACHED BY TELEPHONE ON TWO SEPARATE DAYS. IN MAY 2006, THE PATIENT GOT A READING OF "69MG/DL" ON THE REPORTED METER. THE PATIENT DID NOT TAKE ANY ACTION AFTER THIS READING WAS OBTAINED. DUE TO GETTING THE LOW RESULT, THE PATIENT REMOVED THE BATTERY OF THE METER FOR SOME UNKNOWN REASON. SHE ATTEMPTED TO USE THE METER AGAIN BUT NOTICED THE TIME FLASHING ON THE METER'S DISPLAY AND DID NOT KNOW HWO TO RESOLVE THE ISSUE. THE PATIENT DID NOT ATTEMPT TO RETEST. AN UNKNOWN TIME LATER THE PATIENT DEVELOPED SYMPTOMS OF DIZZINESS AND HER RIGHT EYE STARTED TO HAVE BLURRY VISION. THE PATIENT WAITED MORE THAN 30 MINUTES LATER FO RHER HUSBAND TO TAKE HER TO THE HOSPITAL. THE PATIENT'S "GLUCOPHAGE" MEDICATION REGIMEN WAS CHANGED FROM 2 TO 3 PILLS. IT IS NOT KNOWN WHAT FREQUENCY THE MEDICATION WAS TO BE TAKEN. THE CUSTOMER CARE ADVOCATE (CCA) ALSO DOCUMENTED READINGS OF "169, 105, AND 158 MG/DL" THESE READINGS WERE RANDOM RESULTS THAT THE PATIENT OBTAINED ON HER METER AFTER THE WEEK OF MAY 3,2006. THE METER, TEST STRIPS, AND CONTROL SOLUTION WERE REPLACED. THIS COMPLAINT IS BEING REPORTED SINCE THE PATIENT WAS UNABLE TO USE THE METER, SHE DEVELOPED SYMPTOMS AND WAS GIVEN INSULIN TREATMENT AT A HOSPITAL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 OT ULTRA METER GLUCOSE MONITORING SYS/KIT NBW LIFESCAN, INC. NA 2632716

    Patients

    Seq Age Sex Outcome Treatment
    1 40 YR Hospitalization| L| R