BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ONE TOUCH ULTRA

    MDR report key: 588585 · Received April 5, 2005

    Report

    Report Number
    2939301-2005-01480
    Event Type
    Injury
    Date Received
    April 5, 2005
    Report Date
    April 4, 2005
    Manufacturer
    LIFESCAN, INC.
    Product Code
    CFR
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    PATIENT

    Narratives

    Description of Event or Problem · 1

    THE PATIENT'S SPOUSE CALLED LIFESCAN AND ALLEGED THAT THEIR SPOUSE'S METER JAD AM IMLMPWM OSSIE AMD WAS IMAN;E TP TEST PM TJEOR ,ETER FPR 3 WEEKS. MEDICAL AFFAIR SPOKE TO THE PATIENT THE FOLLOWING DAY AND OBTAINED/VERIFIED THE FOLLOWING INFORMATION. THE PATIENT STATED THAT THEY WERE UNABLE TO TEST ON THEIR METER FOR THE PAST 3 WEEKS. THEY ATTEMPTED TO TEST ON TWO DIFFERENT OCCASIONS DURING THAT TIME, BUT WASUNABLE TO OBTAIN A RESULT. THE PATIENT STATED THAT TWO DAYS PRIOR TO THE HOSPITALIZATION, THEY BEGAN TO FEEL ILL. JUST BEFORE GOING TO THE HOSPITAL, THE PATIENT BEGAN VOMITING AND COLLAPSED. IN THE HOSPITAL, THEY WERE DIAGNOSED WITH DIABETIC KETOACIDOSIS. THEIR BLOOD GLUCOSE WAS 342 MG/DL AND THEY WERE TREATED WITH INSULIN AND AN IV TO RESTORE FLUIDS IN THEIR BODY. THE PATIENT NORMALLY TAKES NOVOLIN AND NOVOLOG BASED ON A SLIDING SCALE. THEY CONTINUED TO TAKE THEIR NOVOLIN, BUT ONLY TOOK THE MINIMUM AMOUNT OF NOVOLOG. THE MEDICAL AFFAIRS SPECIALIST WAS UNABLE TO OBTAIN MORE INFORMATION BECAUSE THE PATIENT HAD JUST RETURNED HOME FROM THE HOSPITAL AND WAS NOT FEELING WELL. NEITHER THE PATIENT, NOR THEIR SPOUSE COULD EXPLAIN THE PROBLEM WITH THE METER. THE PATIENT STATED THAT THEY WOULD ENTER THE TEST STRIP AND NOTHING WOULD HAPPEN. WHEN THE PATIENT'S SPOUSE WAS TROUBLESHOOTING WITH THE LFS CUSTOMER CARE REPRESENTATIVE, THEY WERE ABLE TO POWER THE METER ON BY INSERTING A TEST STRIP. A REPLACEMENT METER HAS BEEN SENT.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 50 YR Hospitalization| L| R