BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACCU-CHEK SPIRIT CARTRIDGE

    MDR report key: 2861506 · Received November 28, 2012

    Report

    Report Number
    2183996-2012-01793
    Event Type
    Malfunction
    Date Received
    November 28, 2012
    Date of Event
    November 13, 2012
    Report Date
    March 26, 2013
    Manufacturer
    ROCHE INSULIN DELIVERY SYSTEMS INC.
    Product Code
    LZG
    PMA / PMN Number
    K060876
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    PRODUCT WAS RECEIVED ON (B)(4) 2013. THE RECEIVED USED CARTRIDGE WAS VISUALLY, LEAK AND GLIDE FORCE TESTED. CARTRIDGE 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.

    Description of Event or Problem · 1

    ON (B)(6) 2012, THE PT REPORTED THAT SHE NOTICED CONDENSATION IN THE CARTRIDGE COMPARTMENT OF HER INFUSION DEVICE. THE PT THINKS THE CONDENSATION IS FROM A LEAKY INSULIN CARTRIDGE. THERE WAS ONLY A SMALL AMOUNT OF CONDENSATION AND SHE WAS ABLE TO CLEAN IT OUT USING A Q-TIP. SHE STATED IT SMELLED LIKE INSULIN AND THERE WAS ALSO CONDENSATION IN THE BOTTOM OF THE INSULIN CARTRIDGE WHERE SHE THINKS THE LEAK OCCURRED. NO PHYSIOLOGICAL EFFECTS WERE REPORTED. THE PT DID NOT REQUIRE MEDICAL ASSISTANCE FROM A HEALTHCARE PROFESSIONAL OR SECOND PARTY TO ADDRESS THE ISSUE. INSULIN CARTRIDGE, ADAPTER, AND INFUSION SET WERE REQUESTED TO BE RETURNED FOR PRODUCT EVAL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ACCU-CHEK SPIRIT CARTRIDGE LZG ROCHE INSULIN DELIVERY SYSTEMS INC. NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 62 YR INSULIN| RELATED ACCESSORIES| INSULIN INFUSION PUMP