BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ACCU-CHEK ® 3.15 ML INSULIN CARTRIDGE

    MDR report key: 3925426 · Received July 10, 2014

    Report

    Report Number
    1823260-2014-05080
    Event Type
    Injury
    Date Received
    July 10, 2014
    Date of Event
    March 21, 2014
    Report Date
    August 26, 2014
    Manufacturer
    ROCHE DIAGNOSTICS
    Product Code
    LZG
    PMA / PMN Number
    K111353
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NJ, US
    Reporter Occupation
    PATIENT

    Narratives

    Additional Manufacturer Narrative · 1

    IT WAS UNKNOWN IF THE INITIAL REPORTER SENT REPORT TO THE FDA.

    Description of Event or Problem · 1

    CUSTOMER REPORTED SHE RECEIVED TREATMENT AT A HOSPITAL FOR HYPERGLYCEMIA, WHICH WAS CAUSED BY E4 OCCLUSION ERRORS. SHE CHANGED THE INFUSION SET FOLLOWING THE E4 ERROR, BUT THE ERROR REAPPEARED WHEN SHE STARTED THE INFUSION DEVICE. SHE FELT SICK AND SLEEPY, AND HER BLOOD GLUCOSE MONITOR READ "HI" MG/DL. SHE DRANK FLUIDS AND WAS TRANSPORTED TO THE HOSPITAL BY HER MOTHER AT 9:00 P.M. HER BLOOD GLUCOSE ON THE HOSPITAL MONITOR WAS IN THE 400-500'S MG/DL. SHE WAS TREATED WITH IV FLUIDS AND AN INJECTION OF LONG-ACTING INSULIN. SHE WAS NOT ADMITTED TO THE HOSPITAL AND LEFT ABOUT 6 HOURS LATER. SHE STARTED HER BACKUP INFUSION DEVICE USING A NEW CARTRIDGE AND INFUSION SET AND HAS EXPERIENCED NO FURTHER CONCERNS. HER NORMAL BLOOD GLUCOSE RANGE IS 90- 230 MG/DL. SHE WAS UNSURE WHAT CAUSED THE E4 ERRORS AND WAS UNABLE TO TROUBLESHOOT THE INFUSION DEVICE. THE INFUSION SET, CARTRIDGE, AND ADAPTER WERE REQUESTED FOR EVALUATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    403769 ACCU-CHEK ® 3.15 ML INSULIN CARTRIDGE INSULIN INFUSION PUMP ACCESSORY LZG ROCHE DIAGNOSTICS NA ASKU

    Patients

    Seq Age Sex Outcome Treatment
    1 017 YR Hospitalization| R HUMALOG