BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ANIMAS INSULIN CARTRIDGE

    MDR report key: 2076312 · Received April 22, 2011

    Report

    Report Number
    2531779-2011-02761
    Event Type
    Malfunction
    Date Received
    April 22, 2011
    Date of Event
    March 26, 2011
    Report Date
    March 26, 2011
    Manufacturer
    ANIMAS CORP.
    Product Code
    LZG
    PMA / PMN Number
    K032257
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WI, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4): A VISUAL INSPECTION OF THE CARTRIDGE WAS PERFORMED. NO DAMAGE OR DEFECTS WERE NOTED. A LEAK TEST, FILL TEST, AND FORCE TEST WAS PERFORMED WITH NO FAILURES OBSERVED. EACH CARTRIDGE LOT IS SUBJECTED TO A STATISTICAL SAMPLING PLAN AND MUST PASS TESTING FOR FORCE (OCCLUSION AND LOSS OF PRIME), CRACKS, AND FOREIGN MATERIAL PRIOR TO RELEASE FOR DISTRIBUTION.

    Additional Manufacturer Narrative · 1

    THE CARTRIDGE HAS NOT BEEN RETURNED TO ANIMAS. IF THE DEVICE IS RETURNED, AN EVAL 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 PT REPORTED THAT SHE HAD 3 CARTRIDGES FROM LOT# B201517 THAT LEAKED AT THE NEEDLE CONNECTION DURING THE FILL STEP. SHE STATED THAT SHE NOTICED A LARGE FLAT BUBBLE IN THE CARTRIDGE WHICH WOULD NOT BREAK UP. THE PT DID NOT EXPERIENCE ANY BG EXCURSIONS, AS SHE DID NOT USE THE LEAKING CARTRIDGES SINCE THEY WOULD NOT FILL PROPERLY DURING THIS STEP.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ANIMAS INSULIN CARTRIDGE INSULIN INFUSION PUMP CARTRIDGE LZG ANIMAS CORP. IR 1200/1250/2020/OTP B201517

    Patients

    Seq Age Sex Outcome Treatment
    1 62 YR