BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACCU-CHEK SPIRIT CARTRIDGE

    MDR report key: 2861503 · Received November 28, 2012

    Report

    Report Number
    2183996-2012-01821
    Event Type
    Malfunction
    Date Received
    November 28, 2012
    Date of Event
    November 16, 2012
    Report Date
    November 18, 2012
    Manufacturer
    ROCHE INSULIN DELIVERY SYSTEMS INC
    Product Code
    LZG
    PMA / PMN Number
    K060876
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TN, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Description of Event or Problem · 1

    ON (B)(6) 2012, THE PATIENT REPORTED THAT WHILE HE WAS IN THE HOSPITAL, FOR A STROKE CAUSED BY A CARDIAC INFARCTION, HE NOTICED INSULIN INSIDE HIS INFUSION DEVICE ON (B)(6) 2012. THE PATIENT STATED THAT HIS BLOOD GLUCOSE LEVELS HAD BEEN NORMAL AND THE HOSPITAL LEFT HIM ON THE INFUSION DEVICE. HE FELT WETNESS AND HIS PAJAMAS WERE WET WITH INSULIN. THE INSULIN CARTRIDGE WAS STILL INSIDE THE INFUSION DEVICE, BUT IT WAS EMPTY. THE PATIENT THINKS A RUBBER SEAL INSIDE THE INSULIN CARTRIDGE CAUSED THE CARTRIDGE TO LEAK INSIDE THE INFUSION DEVICE. THE PATIENT'S BLOOD GLUCOSE LEVELS ROSE TO 380-550 MG/DL DUE TO THE INSULIN LEAKING. THE HOSPITAL TOOK HIM OFF OF THE INFUSION DEVICE AND BEGAN INSULIN INJECTIONS. THE PATIENT STATED HE WOULD HAVE BEEN ABLE TO TREAT HIMSELF IF THE NURSES WERE NOT THERE. THE PATIENT'S NORMAL BLOOD GLUCOSE RANGE IS 160-200 MG/DL. THE INSULIN CARTRIDGE AND INFUSION SETS HAVE BEEN DISCARDED AND THEREFORE CANNOT BE RETURNED FOR EVALUATION. THE INFUSION DEVICE WAS REPLACED AND REQUESTED TO BE RETURNED FOR EVALUATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ACCU-CHEK SPIRIT CARTRIDGE LZG ROCHE INSULIN DELIVERY SYSTEMS INC NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 74 YR INSULIN INFUSION PUMP| INSULIN| RELATED ACCESSORIES