BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACCU-CHEK SPIRIT CARTRIDGE

    MDR report key: 2932118 · Received January 18, 2013

    Report

    Report Number
    2183996-2013-00053
    Event Type
    Malfunction
    Date Received
    January 18, 2013
    Date of Event
    January 7, 2013
    Report Date
    February 28, 2013
    Manufacturer
    ROCH HEALTH SOLUTIONS INC.
    Product Code
    LZG
    PMA / PMN Number
    K060876
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NJ, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    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) 2013 PT REPORTED INSULIN LEAKED FROM THE BOTTOM OF THE INSULIN CARTRIDGE WHILE IN USE IN THE INFUSION DEVICE. PT STATED THE CARTRIDGE HAD BEEN IN USE FOR 3 DAYS WHEN THE LEAK WAS NOTICED. PT REPORTED ONLY A COUPLE OF DROPS OF INSULIN HAD LEAKED FROM THE CARTRIDGE PLUNGER INTO THE CARTRIDGE COMPARTMENT OF THE INFUSION DEVICE. PT STATED HE WAS NOT ABLE TO POUR OUT THE INSULIN FROM THE INFUSION DEVICE SO HE DRIED OUT THE INSIDE OF THE CARTRIDGE COMPARTMENT WITH A TISSUE. ADVISED PT TO SWITCH TO A NEW INSULIN CARTRIDGE. PT REPORTED HE SAW THE INSULIN DRIP FORM THE BOTTOM OF THE INSULIN CARTRIDGE WHILE USING IT. PT IS USING A COMPETITOR'S INFUSION SET. NO PHYSIOLOGICAL EFFECTS WERE REPORTED. THE PT DID NOT REQUIRE ASSISTANCE FROM A HEALTHCARE PROFESSIONAL OR SECOND PARTY TO ADDRESS THE ISSUE. PRODUCT WAS REPLACED AND REQUESTED RETURN OF THE ALLEGED INSULIN CARTRIDGE AND INSULIN ADAPTER FOR EVALUATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    28576 ACCU-CHEK SPIRIT CARTRIDGE LZG ROCH HEALTH SOLUTIONS INC. NA 32275329

    Patients

    Seq Age Sex Outcome Treatment
    1 59 YR INSULIN INFUSION PUMP| INSULIN| RELATED ACCESSOREIS