BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ANIMAS INSULIN CARTRIDGE

    MDR report key: 2007885 · Received February 26, 2011

    Report

    Report Number
    2531779-2011-01183
    Event Type
    Malfunction
    Date Received
    February 26, 2011
    Report Date
    January 27, 2011
    Manufacturer
    ANIMAS CORP.
    Product Code
    LZG
    PMA / PMN Number
    K032257
    Removal / Correction Number
    2531779-02/25/11/001-R
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AR, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    ANIMAS PERFORMED INVESTIGATION WITH RETAIN CARTRIDGE LOT B201582. CARTRIDGE LOT# B201582 WAS CONFIRMED TO BE DEFECTIVE AND FOUND TO BE LEAKING FROM THE PLUNGER SIDE OF THE CARTRIDGE PAST THE FIRST O-RING AND OUT THE HOLE BETWEEN THE TWO O-RINGS. CARTRIDGE LEAK AT PLUNGER WAS CONFIRMED. THE PATIENT'S CARTRIDGE HAS BEEN RETURNED TO ANIMAS; HOWEVER, THE INVESTIGATION HAS NOT BEEN COMPLETED. ONCE THE EVALUATION HAS BEEN COMPLETED A SUPPLEMENTAL REPORT WILL BE FILED.

    Description of Event or Problem · 1

    THE PATIENT CLAIMED THAT HER BLOOD GLUCOSE LEVELS (BG) HAVE BEEN ELEVATED SINCE NOON YESTERDAY: HER BG WAS 344 MG/DL AT THE TIME. SHE STATED THAT 2 HOURS AFTER CORRECTING HER BG LEVEL, IT REMAINED ELEVATED AT 258 MG/DL. THE PATIENT FELT THAT HER PUMP WAS NO LONGER DELIVERING THE BASAL RATE. THE ANIMAS REPRESENTATIVE WENT THROUGH TROUBLESHOOTING. THE PATIENT CONFIRMED THAT THE PUMP SETTINGS WERE CORRECT AND THERE WERE NO ISSUES INFUSION SITE/SET; HOWEVER, THE PATIENT DISCOVERED THERE WAS MOISTURE AND INSULIN IN THE CARTRIDGE COMPARTMENT. THE PATIENT STATED THAT SHE FELT INSULIN LEAKING FROM THE BOTTOM OF THE CARTRIDGE. THE PATIENT WAS ADVISED TO USE A DIFFERENT BOX OF CARTRIDGES AND TO MONITOR HER BG LEVELS. THERE WAS NO ADVERSE EVENT ASSOCIATED WITH THIS COMPLAINT; HOWEVER, THIS COMPLAINT IS BEING REPORTED DUE TO THE INSULIN LEAKING IN THE CARTRIDGE COMPARTMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ANIMAS INSULIN CARTRIDGE INSULIN CARTRIDGE LZG ANIMAS CORP. IR1200/1250/2020/OTP B201582

    Patients

    Seq Age Sex Outcome Treatment
    1