BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACCU-CHEK SPIRIT CARTRIDGE

    MDR report key: 3012058 · Received March 20, 2013

    Report

    Report Number
    2183996-2013-00437
    Event Type
    Malfunction
    Date Received
    March 20, 2013
    Date of Event
    March 5, 2013
    Report Date
    July 31, 2025
    Manufacturer
    ROCHE DIABETES CARE AG
    Product Code
    LZG
    PMA / PMN Number
    NA
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 1

    THE INCIDENT OCCURRED OUTSIDE THE UNITED STATES. INFORMATION CONTAINED WITHIN THIS REPORT IS ALL THAT IS AVAILABLE AT THIS TIME. IF FURTHER INFORMATION IS OBTAINED, IT WILL BE PROVIDED IN THE SUPPLEMENTAL REPORT.

    Additional Manufacturer Narrative · 1

    CONCLUSION THE COMPLAINT DESCRIBING A LEAKAGE CANNOT BE VERIFIED. CARTRIDGE MEETS THE SPECIFICATION. RESULT THE ONE USED AND ONE UNUSED RECEIVED CARTRIDGES WERE VISUALLY, LEAK AND GLIDE FORCE TESTED. CARTRIDGES PASSED THE VISUAL TEST AND THE LEAKAGE TEST AT DIFFERENT POSITIONS OF THE PLUNGER ROD. THE GLIDE FORCE MEASURED IS IN ACCORDANCE WITH PRODUCT SPECIFICATIONS. THE PROBLEM MENTIONED BY THE CUSTOMER COULD NOT BE REPRODUCED.

    Description of Event or Problem · 1

    ON (B)(6) 2013, IT WAS REPORTED THAT THE PATIENT'S BLOOD GLUCOSE LEVEL HAD BEEN ELEVATED TO 543 MG/DL. THE PATIENT NOTICED INSULIN LEAKING FROM THE CARTRIDGE OF THE INFUSION DEVICE. THE PATIENT CHANGED THE INSULIN CARTRIDGE AND HAD NO FURTHER PROBLEMS. THE PATIENT DID NOT REQUIRE MEDICAL ASSISTANCE FROM A HEALTHCARE PROFESSIONAL OR SECOND PARTY TO ADDRESS THE ISSUE. INSULIN CARTRIDGE WAS REQUESTED TO BE RETURNED FOR PRODUCT EVALUATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    116596 ACCU-CHEK SPIRIT CARTRIDGE INSULIN CARTRIDGE LZG ROCHE DIABETES CARE AG 00700006871 32294312

    Patients

    Seq Age Sex Outcome Treatment
    1 52 YR Female