BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACCU-CHEK CARTRIDGE

    MDR report key: 2002105 · Received February 4, 2011

    Report

    Report Number
    2183996-2011-00127
    Event Type
    Malfunction
    Date Received
    February 4, 2011
    Date of Event
    December 26, 2010
    Report Date
    January 17, 2011
    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
    VA, US
    Reporter Occupation
    UNKNOWN

    Narratives

    Description of Event or Problem · 1

    ON (B)(6) 2011, SISTER REPORTED CONDENSATION IN THE CARTRIDGE COMPARTMENT OF THE INFUSION DEVICE. THE INSULIN CARTRIDGE WAS REMOVED FROM THE INFUSION DEVICE, AND THE OUTSIDE OF THE CARTRIDGE WAS "STICKY'. PT BELIEVED THE CARTRIDGE LEAKED INSULIN. THIS CONCERN HAS BEEN ONGOING SINCE (B)(6) 2010. THIS HAPPENED WITH TWO BOXES OF CARTRIDGES, BOTH FROM THE SAME LOT. PT INSERTS THE CARTRIDGE INTO THE INFUSION DEVICE WITHOUT PROPERLY ATTACHING THE ADAPTER AND TUBING FIRST. PT DRIED THE CARTRIDGE CHAMBER WITH A Q-TIP AND WAS ADVISED TO USE BACKUP INFUSION DEVICE FOR 24 HOURS. F/U WAS COMPLETED WITH SISTER ON (B)(6) 2011. PT CONTINUED TO USE PRIMARY INFUSION DEVICE. THE CONDENSATION CONTINUED EVEN WHILE OBSERVING PROPER TECHNIQUE WITH THE CARTRIDGE CHANGE. SISTER ADVISED PT WOULD SWITCH TO BACKUP INFUSION DEVICE ON (B)(6) 2011. THREE ADD'L ATTEMPTS WERE MADE TO F/U WITH PT, AND THESE WERE UNSUCCESSFUL. INSULIN CARTRIDGE WAS REPLACED AND REQUESTED FOR EVAL. NO PHYSIOLOGICAL EFFECTS WERE REPORTED. THE PT 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
    1 ACCU-CHEK CARTRIDGE INSULIN INFUSION PUMP CARTRIDGE LZG ROCHE INSULIN DELIVERY SYSTEMS INC. NA 32072330

    Patients

    Seq Age Sex Outcome Treatment
    1 69 YR INSULIN INFUSION SET| INSULIN| INSULIN INFUSION DEVICE