BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ONE TOUCH ULTRA METER

    MDR report key: 1060282 · Received June 10, 2008

    Report

    Report Number
    2939301-2008-01042
    Event Type
    Injury
    Date Received
    June 10, 2008
    Report Date
    May 14, 2008
    Manufacturer
    LIFESCAN, INC.
    Product Code
    NBW
    PMA / PMN Number
    NA
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    LAY USER/PATIENT

    Narratives

    Description of Event or Problem · 1

    IN 2008, THE LAY USER/PT CONTACTED LIFESCAN (LFS) ALLEGING HER ONE TOUCH ULTRA METER NO LONGER POWERED ON. THE COMPLAINT WAS CLASSIFIED BASED ON THE CONVERSATION THE CUSTOMER CARE ADVOCATE (CCA) HAD WITH THE PT, SINCE THE MEDICAL AFFAIRS SPECIALIST (MAS) WAS UNABLE TO REACH THE PT BY PHONE. IT IS UNCLEAR WHEN THE ALLEGED ISSUE BEGAN PRIOR TO CONTACTING LFS. ON THE SAME DAY, THE PT CONTACTED LFS TO INQUIRE ABOUT THE STATUS OF A FREE METER THROUGH AN UPGRADE OFFER. DURING THE CONVERSATION, THE PT REPORTED TO THE CCA THAT HER PREVIOUS METER HAD STOPPED WORKING. SHE MENTIONED IT NO LONGER POWERED ON EVEN AFTER REPLACING THE BATTERY. SOMETIME AFTER THE REPORTED ISSUE BEGAN (DATE/TIME UNK), THE PT REPORTED DEVELOPING THE FOLLOWING SYMPTOMS: "DIZZY, EXTREME THIRST, LIGHT-HEADED, AND A HEADACHE." IT IS UNK WHAT ACTIONS THE PT TOOK, IF ANY, TO RELIEVE THESE SYMPTOMS. IN ADDITION, THE PT CLAIMED ABOUT THREE MONTHS PRIOR TO CONTACTING LFS SHE HAD TO GO TO THE EMERGENCY ROOM (ER). THE PT CLAIMS SHE WENT TO THE ER BECAUSE SHE WAS "WAS LOOSING FEELING IN HER ARM AND LOST HER PULSE." IT IS UNCLEAR WHAT TYPE OF TREATMENT THE PT RECEIVED, BUT CLAIMS SHE WAS TOLD SHE WAS IN A "DIABETES COMA." DURING THAT VISIT TO THE ER, THE PT WAS TESTED ON THE HOSPITAL'S METER AND OBTAINED A RESULT OF "435 MG/DL." IT WOULD HAVE BEEN HELPFUL TO CONFIRM THE FOLLOWING WITH THE PT: TESTING FREQUENCY, DIABETES MEDICATION, APPROXIMATE DATE METER STOPPED WORKING, ACTIONS PT TOOK REGARDING HER DIABETES TREATMENT AFTER THE METER STOPPED WORKING, SYMPTOMS SHE DEVELOPED AFTER THE ALLEGED ISSUE BEGAN, APPROXIMATE DATE PT WENT TO THE EMERGENCY ROOM (ER) AND REASON FOR VISIT, TREATMENT OBTAINED IN THE ER, AND CONFIRM IF THE PT WAS ADMITTED TO THE HOSP. THIS COMPLAINT IS BEING REPORTED BECAUSE THE PT CLAIMS, SHE WAS UNABLE TO TEST HER BLOOD GLUCOSE DUE TO THE ALLEGED ISSUE AND REPORTEDLY DEVELOPED SYMPTOMS SUGGESTIVE OF HYPERGLYCEMIA AFTER THE REPORTED METER ISSUE BEGAN, AND REPORTEDLY HAD TO RECEIVE MEDICAL INTERVENTION.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 27 YR Hospitalization| L| R