BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ACCU-CHEK SPIRIT CARTRIDGE

    MDR report key: 1231664 · Received November 14, 2008

    Report

    Report Number
    2183996-2008-01723
    Event Type
    Injury
    Date Received
    November 14, 2008
    Date of Event
    November 1, 2008
    Report Date
    November 1, 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
    IL, US
    Reporter Occupation
    UNKNOWN

    Narratives

    Additional Manufacturer Narrative · 1

    NO PRODUCT WILL BE RETURNED FOR EVAL.

    Description of Event or Problem · 1

    IN 2008, THE PT REPORTED SHE HAS HAD TO USE MORE INSULIN THAN NORMAL. SHE SAID THIS WAS BECAUSE SHE HAS HAD TOO MANY AIR BUBBLES IN HER INSULIN INFUSION SET TUBING THAT SHE HAD TO PRIME OUT. SHE STATED HER BLOOD GLUCOSE READING WAS 92 MG/DL WHEN SHE CHANGED THE INSULIN CARTRIDGE YESTERDAY BUT TODAY SHE WOKE UP WITH A READING OF 172 MG/DL AND HAS HAD THE FOLLOWING READINGS TODAY: 140, 266, 299 AND 191 MG/DL. SHE SAID HER CURRENT READING IS 155 MG/DL. SHE STATED SHE EXPERIENCES MIGRAINE HEADACHES WHEN SHE HAS ELEVATED READINGS. SHE SAID SHE DOES NOT CURRENTLY HAVE ANY AIR BUBBLES IN THE CARTRIDGE. THE PT REQUESTED ADDITIONAL TRAINING AND A REQUEST WAS SENT. COURTESY CARTRIDGES WERE SENT TO THE PT. THE PT DID NOT REQUIRE ASSISTANCE FROM A HEALTHCARE PROFESSIONAL OR SECOND PARTY TO ADDRESS THE ISSUE. NO PRODUCT WAS REQUESTED TO BE RETURNED FOR EVAL.

    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 322072748

    Patients

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