BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ACCU-CHEK SPIRIT CARTRIDGE

    MDR report key: 1063150 · Received June 20, 2008

    Report

    Report Number
    2183996-2008-00918
    Event Type
    Injury
    Date Received
    June 20, 2008
    Date of Event
    June 10, 2008
    Report Date
    June 10, 2008
    Manufacturer
    DISETRONIC MEDICAL SYSTEMS
    Product Code
    FPA
    PMA / PMN Number
    K060876
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    UNKNOWN

    Narratives

    Additional Manufacturer Narrative · 1

    NO PRODUCT WILL BE RETURNED FOR EVALUATION.

    Description of Event or Problem · 1

    IN '08, THE PATIENT AND HER HUSBAND REPORTED AN ELEVATED BLOOD GLUCOSE READING OF 23 MMOL/L (414 MG/DL) WITH HER TYPICAL READING FOR THAT TIME OF NIGHT BEING 4-7 MMOL/L (72-126 MG/DL). SYMPTOMS WERE THIRST AND FEELING FLUSHED AND THE PATIENT TREATED HER READING BY GIVING HERSELF BOLUSES THROUGH HER INSULIN INFUSION DEVICE. TO TROUBLESHOOT , THE PATIENT WAS INSTRUCTED TO DISCONNECT FROM HER INFUSION HEADSET AND BOLUS INTO THE AIR. INSULIN DRIPPED FROM THE END OF THE TUBING. THE PATIENT CONFIRMED HER TIME AND BASAL RATES WERE ACCURATE. SHE STATED SHE HAS ONLY BEEN ON HER INFUSION DEVICE FOR 2 WEEKS AND HER DOCTOR IS STILL ADJUSTING HER BASAL RATES. THERE WAS A LARGE AIR BUBBLE IN THE CARTRIDGE WHICH THE PATIENT PRIMED OUT. SHE STATED SHE DOES USE ROOM TEMPERATURE INSULIN. LATER THE SAME DAY, THE PATIENT'S HUSBAND CALLED AND STATED THE PATIENT'S READINGS WERE STILL ELEVATED AT 20 MMOL/L (360 MG/DL). THE PATIENT WAS ADVISED TO GIVER HERSELF AN INSULIN INJECTION AND, IF HER READING DECREASED, TO CONTINUE BOLUSING THROUGH HER INFUSION DEVICE ACCORDING TO HER DOCTOR'S INSTRUCTIONS. THE PATIENT'S HUSBAND CALLED IN THE NEXT DAY, AND STATED THE PATIENT'S BLOOD GLUCOSE READINGS ARE STABILIZED AND SHE IS BACK IN HER NORMAL RANGE. HE SAID SHE TOOK AN INJECTION AND THEN BOLUSED WITH HER INFUSION DEVICE. THE PATIENT DID NOT REQUIRE ASSISTANCE FROM A HEALTHCARE PROFESSIONAL OR SECOND PARTY TO ADDRESS THIS 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 CARTRIDGE INSULIN INFUSION PUMP CARTRIDGE FPA DISETRONIC MEDICAL SYSTEMS NA UNK

    Patients

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