BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ACCU-CHEK SPIRIT CARTRIDGE

    MDR report key: 1231659 · Received November 14, 2008

    Report

    Report Number
    2183996-2008-01729
    Event Type
    Injury
    Date Received
    November 14, 2008
    Date of Event
    October 28, 2008
    Report Date
    October 29, 2008
    Manufacturer
    DISETRONIC MEDICAL SYSTEMS
    Product Code
    LZG
    PMA / PMN Number
    K060876
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    UNKNOWN

    Narratives

    Additional Manufacturer Narrative · 1

    NO PRODUCT WILL BE RETURNED FOR EVALUATION.

    Description of Event or Problem · 1

    IN 2008, THE PATIENT REPORTED THAT HER BLOOD GLUCOSE WAS ELEVATED TO 200 MG/DL AND THERE WERE AIR BUBBLES IN HER INSULIN CARTRIDGE. SHE CALLED PARAMEDICS AND THEY ASSISTED HER WITH REMOVING THE AIR BUBBLES BY USING AN EMPTY SYRINGE. NO TREATMENT WAS PROVIDED TO THE PATIENT BY PARAMEDICS. SHE BOLUSED 3 UNITS OF INSULIN TO LOWER HER BLOOD GLUCOSE. HER NORMAL BLOOD GLUCOSE RANGE IS 90-150 MG/DL. THE PATIENT WAS RESISTANCE TO TROUBLESHOOT WITHOUT THE ASSISTANCE OF HER SPOUSE. SHE STATED THAT THE AIR BUBBLES FORMED A FEW HOURS AFTER THE INSULIN CARTRIDGE WAS INSERTED INTO THE INFUSION DEVICE. SHE STATED THAT SHE USES ROOM TEMPERATURE INSULIN. ON THE SAME DAY THAT PATIENT CALLED BACK. HER HUSBAND WAS EDUCATED ON REMOVING AIR BUBBLES FROM THE INSULIN CARTRIDGE. HE WAS ADVISED TO USE ROOM TEMPERATURE INSULIN AND TO PROPERLY ADJUST THE PISTON ROD PRIOR TO INSERTING THE INSULIN CARTRIDGE. UPON FOLLOW UP ON THE FOLLOWING MONTH, THE PATIENT REPORTED THAT HER BLOOD GLUCOSE HAD RETURNED TO NORMAL. NO PRODUCT WAS REQUESTED TO BE RETURNED FOR EVALUATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ACCU-CHEK SPIRIT CARTRIDGE INSULIN INFUSION PUMP CARTRIDGE LZG DISETRONIC MEDICAL SYSTEMS NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention INSULIN INFUSION PUMP| INSULIN INFUSION SET| INSULIN