BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ACCU-CHEK SPIRIT

    MDR report key: 1063145 · Received June 20, 2008

    Report

    Report Number
    2183996-2008-00926
    Event Type
    Injury
    Date Received
    June 20, 2008
    Date of Event
    June 15, 2008
    Report Date
    June 16, 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
    NC, 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 A VERY SMALL AMOUNT OF INSULIN LEAKED INSIDE THE CARTRIDGE CHAMBER OF HER INSULIN INFUSION DEVICE. SHE STATED SHE LAST CHANGED THE CARTRIDGE FOR TWO TIMES IN THE SAME MONTH, SHE HAD ELEVATED BLOOD GLUCOSE READINGS OF 332 MG/DL AND 226 MG/DL. SHE STATED, SHE ADMINISTERED A STANDARD BOLUS TO CORRECT HER READINGS. SHE SAID AFTER THE LAST ELEVATED READING SHE SMELLED INSULIN AND DISCOVERED INSULIN HAD LEAKED INTO THE CARTRIDGE CHAMBER. THE PATIENT STATED SHE SWITCHED TO HER BACKUP INFUSION DEVICE AND INSERTED A NEW CARTRIDGE FROM A DIFFERENT BOX. SHE SAID THERE APPEARED TO BE NO CRACKS IN THE USED CARTRIDGE AND THERE WAS NOTHING UNUSUAL ABOUT THE BOTTOM PLUNGER AREA OF THE CARTRIDGE. SHE SAID SHE DRIED OUT THE CARTRIDGE CHAMBER ON HER PRIMARY DEVICE AND THREW AWAY THE LEAKY CARTRIDGE ALONG WITH THE BOX FROM WHICH IT CAME. THE PATIENT WAS ADVISED TO SWITCH BACK TO HER PRIMARY DEVICE AFTER INSERTING A NEW CARTRIDGE AND TO CLOSELY MONITOR FOR LEAKS. THE PATIENT STATED HER BLOOD GLUCOSE READING WAS 98 MG/DL AT NOON TODAY WHICH IS WITHIN HER NORMAL RANGE OF 85-120 MG/DL. THE PATIENT DID NOT REQUIRE ASSISTANCE FROM A HEALTHCARE PROFESSIONAL OR SECOND PARTY TO ADDRESS THE ISSUE. NO PRODUCT WAS REQUESTED TO BE RETURNED FOR EVALUATION.

    Devices

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

    Patients

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