BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ANIMAS INSULIN CARTRIDGE

    MDR report key: 2033438 · Received March 23, 2011

    Report

    Report Number
    2531779-2011-01873
    Event Type
    Malfunction
    Date Received
    March 23, 2011
    Report Date
    February 22, 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
    TX, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THERE WAS NO ADVERSE EVENT ASSOCIATED WITH THIS COMPLAINT. THE CARTRIDGE WAS NOT RETURNED TO ANIMAS. THERE IS NO INVESTIGATION NECESSARY. CARTRIDGES WITH LOT # B201582 WERE CONFIRMED TO BE DEFECTIVE. WHEN TESTED, FLUID WAS OBSERVED LEAKING FROM THE PLUNGER END OF THE CARTRIDGE.

    Description of Event or Problem · 1

    ON (B)(6) 2011, THE PT CONTACTED ANIMAS IN RESPONSE TO EMAIL RECEIVED REGARDING FIELD CORRECTION FOR LEAKING CARTRIDGES. THE PT REPORTED THAT ON 2 OR 3 OCCASIONS SHE HAS OBTAINED UNEXPLAINED HIGH BG READINGS IN THE 300-400 MG/DL RANGE WITH NO ASSOCIATED SIGNS OR SYMPTOMS OF A HIGH BG. THE PT'S REPORTED BG READINGS DO NOT MEET ANIMAS' CRITERIA FOR A SERIOUS INJURY. THE PT CLAIMED WHEN SHE OBTAINED THE HIGH BG READINGS SHE DISCONNECTED FROM PUMP, PRIMED TUBING RECONNECTED AND BOLUSED FOR HIGH BG. THE PT REPORTED THAT AT THE TIME OF THE HIGH BG READINGS SHE WAS USING ONE OF THE AFFECTED CARTRIDGE LOT NUMBERS. THE PT FELT THAT THE HIGH BG READINGS WERE AS A RESULT OF THE PUMP NOT ALARMING AN OCCLUSION WAS DETECTED WHEN IT SHOULD HAVE DUE TO ALLEGED ISSUE. THE PT ALSO REPORTED SEEING AN INCREASE IN THE NUMBER OF AIR BUBBLES IN CARTRIDGE WITH THE LOT # SHE IS REPORTING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ANIMAS INSULIN CARTRIDGE INSULIN INFUSION PUMP CARTRIDGE LZG ANIMAS CORP. IR 1200/1250/1250/OTP B201582

    Patients

    Seq Age Sex Outcome Treatment
    1