BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACCU-CHEK SPIRIT CARTRIDGE

    MDR report key: 2971682 · Received January 30, 2013

    Report

    Report Number
    2183996-2013-00132
    Event Type
    Malfunction
    Date Received
    January 30, 2013
    Date of Event
    January 20, 2013
    Report Date
    March 19, 2013
    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
    OH, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    PRODUCT WAS RECEIVED ON (B)(4) 2013. THE RECEIVED USED 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) 2013, THE PT REPORTED THERE WAS MOISTURE IN THE INSULIN CARTRIDGE COMPARTMENT OF HER INFUSION DEVICE. SHE STATED THAT THE MOISTURE SMELLED LIKE INSULIN AND SHE THINKS THE CARTRIDGE IS LEAKING INSULIN NEAR THE PLUNGER. THE PT CLEANED THE INSULIN OUT OF THE COMPARTMENT WITH A COTTON SWAB. THE PT NOTICED THE LEAK BECAUSE HER DEVICE DISPLAYED E (OCCLUSION ERROR); SHE THEN CHANGED THE INSULIN CARTRIDGE AND INFUSION SET. NO PHYSIOLOGICAL EFFECTS WERE REPORTED. THE PT DID NOT REQUIRE MEDICAL ASSISTANCE FROM A HEALTHCARE PROFESSIONAL OR SECOND PARTY TO ADDRESS THE ISSUE. THE INFUSION SETS WERE DISCARDED. THE INFUSION SET, INSULIN CARTRIDGE, AND ADAPTER WERE REQUESTED TO BE RETURNED FOR PRODUCT EVALUATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    41812 ACCU-CHEK SPIRIT CARTRIDGE LZG ROCHE HEALTH SOLUTIONS INC. NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 41 YR ACCESSORIES| INSULIN INFUSION PUMP| INSULIN