BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ACCU-CHEK SPIRIT ADAPTER

    MDR report key: 969824 · Received December 21, 2007

    Report

    Report Number
    2183996-2007-01845
    Event Type
    Injury
    Date Received
    December 21, 2007
    Date of Event
    December 4, 2007
    Report Date
    December 5, 2007
    Manufacturer
    DISETRONIC MEDICAL 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
    PA, US
    Reporter Occupation
    UNKNOWN

    Narratives

    Description of Event or Problem · 1

    THE PATIENT REPORTED ELEVATED BLOOD GLUCOSE READINGS YESTERDAY FROM 182-484 MG/DL. HE STATED HE GOT A FLU SHOT AND THE ELEVATED READINGS STARTED AFTER THAT. DURING TROUBLESHOOTING, THE PATIENT STATED HIS INSULIN INFUSION DEVICE GAVE A LOW CARTRIDGE ALARM AND HE HAS ADVISED TO CHANGE HIS CARTRIDGE SOON. HE STATED HE CHANGED HIS INFUSION SET YESTERDAY BUT IT DID NOT MAKE A DIFFERENCE IN HIS READINGS. THE PATIENT WAS INSTRUCTED TO RUN A PRIME WHICH HE DID WITHOUT ERROR. HE STATED HE HAS SEEN INSULIN DRIPPING OUT AT THE CONNECTION OF THE ADAPTER TO THE INFUSION TUBING TWICE. HE SAID IT IS NOT A BIG LEAK BUT IT IS WET AROUND THE CONNECTION. THE PATIENT WAS SENT A NEW ADAPTER. ON FOLLOW-UP, THE PATIENT STATED THE LEAKS AROUND THE ADAPTER HAS STOPPED AND HIS READINGS ARE BETTER. THE PATIENT DID NOT REQUIRE ASSISTANCE FROM A HEALTHCARE PROFESSIONAL OR SECOND PARTY TO ADDRESS THE ISSUE. THE PRODUCT WAS REPLACED AND REQUESTED TO BE RETURNED FOR EVALUATION.

    Devices

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

    Patients

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