BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACCU-CHEK ® SPIRIT CARTRIDGE

    MDR report key: 3221230 · Received July 11, 2013

    Report

    Report Number
    2183996-2013-01267
    Event Type
    Malfunction
    Date Received
    July 11, 2013
    Date of Event
    June 22, 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
    TN, US
    Reporter Occupation
    OTHER
    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

    THE DELIVERY ACCURACY OF THE INSULIN PUMP WAS TESTED WITHIN THE PUMP DRIVE TEST ON THE DIAGNOSTIC TEST SYSTEM AND MEETS THE SPECIFICATIONS. THE TECHNICAL INVESTIGATION GAVE NO EVIDENCE THAT THE DEVICE DID CAUSE OR CONTRIBUTE TO THE CONDITION REPORTED BY THE PATIENT.

    Description of Event or Problem · 1

    ON (B)(6) 2013, THE PATIENT REPORTED THAT HER INSULIN CARTRIDGE HAD LEAKED. SHE STATED THAT INSULIN WAS IN THE CARTRIDGE COMPARTMENT OF THE INFUSION DEVICE DUE TO THE LEAK. SHE STATED THAT EVERY TIME SHE CHANGES THE CARTRIDGE SHE HAS TO CLEAN OUT INSULIN IN THE COMPARTMENT. NO PHYSIOLOGICAL EFFECTS WERE REPORTED. THE PATIENT DID NOT REQUIRE MEDICAL ASSISTANCE FROM A HEALTHCARE PROFESSIONAL OR SECOND PARTY TO ADDRESS THE ISSUE. THE INSULIN CARTRIDGE, ADAPTER, AND INFUSION DEVICE WERE REPLACED AND WERE REQUESTED TO BE RETURNED FOR PRODUCT EVALUATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    320133 ACCU-CHEK ® SPIRIT CARTRIDGE INSULIN INFUSION PUMP ACCESSORY LZG ROCHE HEALTH SOLUTIONS INC NA 32053201

    Patients

    Seq Age Sex Outcome Treatment
    1 59 YR Female HUMOLOG| HUMOLOG