BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ACCU-CHEK SPIRIT

    MDR report key: 1842755 · Received September 14, 2010

    Report

    Report Number
    2183996-2010-01098
    Event Type
    Injury
    Date Received
    September 14, 2010
    Date of Event
    April 16, 2010
    Report Date
    April 29, 2010
    Manufacturer
    ROCHE INSULIN DELIVERY SYSTEMS INC
    Product Code
    LZG
    PMA / PMN Number
    K060876
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SC, US
    Reporter Occupation
    UNKNOWN

    Narratives

    Description of Event or Problem · 1

    ON (B)(6) 2010, THE PT'S MOTHER REPORTED THAT ON (B)(6) 2010, THE PT HAD A VIRUS AND WAS VOMITING ALL NIGHT. AT 1 PM ON (B)(6) 2010, THE PT STOPPED VOMITING AND LAID DOWN. THE MOTHER NOTICED THE PT BREATHING HEAVILY AND THE PT WAS UNRESPONSIVE. THE MOTHER TESTED THE PT'S BLOOD GLUCOSE AND IT MEASURED "HI" ON HER BLOOD GLUCOSE MONITOR. SHE INJECTED THE PT WITH 25 UNITS OF INSULIN AND CHANGED ALL OF THE INFUSION DEVICE ACCESSORIES. SHE TESTED THE PT'S BLOOD GLUCOSE AGAIN AND IT STILL MEASURED "HI" AND SHE INJECTED HER WITH ANOTHER 25 UNITS OF INSULIN. SHE SWITCHED THE PT TO THE BACKUP INFUSION DEVICE AND WAS STILL UNABLE TO LOWER HER BLOOD GLUCOSE. AT 11 PM SHE TOOK THE PT TO THE EMERGENCY ROOM. THE HOSPITAL STAFF DISCONNECTED THE PT FROM THE INFUSION DEVICE. HER BLOOD GLUCOSE MEASURED 750 MG/DL AND SHE WAS DIAGNOSED WITH KETOACIDOSIS. SHE WAS TREATED WITH IV FLUIDS AND IV INSULIN. SHE WAS HOSPITALIZED FOR 1 WEEK AND TREATED WITH INSULIN INJECTIONS. WHEN SHE WAS RELEASED FROM THE HOSPITAL SHE RECONNECTED TO THE INFUSION DEVICE PER HER PHYSICIAN AND SHE HAS HAD NO FURTHER ISSUES. THE DAY OF THE INCIDENT THE MOTHER NOTICED INSULIN LEAKING AT THE LUER CONNECTION AND INSULIN LEAKED INTO THE CARTRIDGE COMPARTMENT OF THE INFUSION DEVICE. SHE STATED SHE MAY NOT HAVE PROPERLY TIGHTENED THE INFUSION TUBING. THE INFUSION DEVICE WAS REQUESTED TO BE RETURNED FOR EVAL. THE ACCESSORIES IN USE AT THE TIME OF THE INCIDENT HAD BEEN DISCARDED.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 14 YR Hospitalization| O| R INSULIN| INSULIN INFUSION SET