BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACCU-CHEK SPIRIT CARTRIDGE

    MDR report key: 2971667 · Received January 30, 2013

    Report

    Report Number
    2183996-2013-00106
    Event Type
    Malfunction
    Date Received
    January 30, 2013
    Date of Event
    January 15, 2013
    Report Date
    August 4, 2025
    Manufacturer
    ROCHE HEALTH SOLUTIONS INC.
    Product Code
    LZG
    PMA / PMN Number
    K060876
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    THE COMPLAINT CAN BE VERIFIED. E6 MECHANICAL ERRORS WERE FOUND IN THE HISTORY. THE PUMP CORRECTLY TRIGGERED THE E6 ERROR MESSAGES DUE TO TEMPORARY STEP LOSS BY TOO HIGH FRICTION. THE SOFT COMPONENT OF THE ADAPTER IS WORN-OUT AND CONTAMINATED. THE CONTAMINATION DOES NOT AFFECT THE PROBLEM DESCRIBED BY THE CUSTOMER. THE BATTERY COVER PASSED THE OPTICAL INSPECTION.

    Description of Event or Problem · 1

    ON (B)(6) 2013, PATIENT REPORTED A CARTRIDGE LEAKED INSULIN INTO THE INFUSION DEVICE. HE DISCOVERED THE LEAK WHILE CHANGING THE CARTRIDGE. HE DOES HEAR AN AUDIBLE CLICK WHEN THE INFUSION TUBE IS ATTACHED TO THE HEADSET. THERE WAS NO APPARENT DAMAGE TO THE CARTRIDGE. HE CLEANED THE INSULIN WITH A DRY CLOTH. THE CARTRIDGE WAS DISCARDED AND WILL NOT BE RETURNED FOR EVALUATION. NO PHYSIOLOGICAL EFFECTS WERE REPORTED, AND THE PATIENT DID NOT REQUIRE TREATMENT FROM A HEALTH CARE PROFESSIONAL OR SECOND PARTY TO ADDRESS THE ISSUE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    41875 ACCU-CHEK SPIRIT CARTRIDGE Pump, infusion, insulin LZG ROCHE HEALTH SOLUTIONS INC. NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 56 YR Male INSULIN | INSULIN INFUSION PUMP| RELATED ACCESSORIES| INSULIN INFUSION PUMP| RELATED ACCESSORIES| INSULIN