BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ANIMAS INSULIN CARTRIDGE

    MDR report key: 2050469 · Received April 5, 2011

    Report

    Report Number
    2531779-2011-02257
    Event Type
    Malfunction
    Date Received
    April 5, 2011
    Date of Event
    March 7, 2011
    Report Date
    March 7, 2011
    Manufacturer
    ANIMAS CORP.
    Product Code
    LZG
    PMA / PMN Number
    K032257
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    THE CARTRIDGE HAS NOT BEEN RETURNED TO ANIMAS. IF THE DEVICE IS RETURNED, AN EVALUATION SHALL BE COMPLETED AND A SUPPLEMENTAL REPORT WILL BE FILED. NO CONCLUSIONS CAN BE MADE AT THIS TIME.

    Description of Event or Problem · 1

    THE PATIENT REPORTED THAT HE HAD 5 CARTRIDGES FROM LOT NUMBER B201524 THAT HAVE ALL LEAKED WHILE FILLING THE CARTRIDGES FROM THE LUER LOCK CONNECTION. HE STATED THAT THE CARTRIDGE COMPARTMENT IS DRY. THE PATIENT REPORTED THAT HIS CURRENT BG WAS 246 MG/DL, AND THAT HE HAS EXPERIENCED BG EXCURSIONS WITHOUT SYMPTOMS. HE REPORTED THAT HE HAS HAD A SEVERE COLD AND IS NOT SURE HOW MUCH OF THE BG EXCURSIONS ARE DUE TO THE COLD VERSUS THE CARTRIDGE LEAKS. THE PATIENT STATED THAT THERE DOES NOT APPEAR TO BE VISIBLE DAMAGE TO THE CARTRIDGES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ANIMAS INSULIN CARTRIDGE INSULIN INFUSION PUMP CARTRIDGE LZG ANIMAS CORP. 1200/1250/2020/OTP B201524

    Patients

    Seq Age Sex Outcome Treatment
    1 62 YR