BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ANIMAS INSULIN CARTRIDGE

    MDR report key: 2098153 · Received May 20, 2011

    Report

    Report Number
    2531779-2011-03514
    Event Type
    Malfunction
    Date Received
    May 20, 2011
    Date of Event
    April 21, 2011
    Report Date
    April 23, 2011
    Manufacturer
    ANIMAS CORPORATION
    Product Code
    LZG
    PMA / PMN Number
    K032257
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    COMMON DEVICE NAME: INSULIN INFUSION PUMP CARTRIDGE. CATALOG #: 100-124-01. (B)(6). 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.

    Additional Manufacturer Narrative · 1

    (B)(4). DEVICE EVALUATION: THE CARTRIDGES WERE RETURNED AND EVALUATED BY PRODUCT ANALYSIS ON (B)(4) 2011 WITH THE FOLLOWING FINDINGS: THE CARTRIDGES PASSED VISUAL INSPECTION, NO DAMAGE OR DEFECTS WERE OBSERVED TO THE LUER, O-RINGS, PLUNGER, OR CARTRIDGE BODY. A FORCE TEST WAS PERFORMED WITH NO FAILURES AT THE CONCLUSION OF TESTING.

    Description of Event or Problem · 1

    A FAMILY MEMBER REPORTED THAT THE PATIENT HAS BEEN EXPERIENCING ELEVATED BLOOD GLUCOSE (BG) BETWEEN 245 MG/DL AND 362 MG/DL POST-MEAL AT INTERVALS SINCE RETURNING FROM VACATION ON (B)(6) 2011. THE FAMILY MEMBER STATED, THE PATIENT HAS NOT EXPERIENCED ANY SYMPTOMS AND DID NOT HAVE KETONES. SHE REPORTED THAT CORRECTIONS FOR THE ELEVATED BGS HAVE BEEN GIVEN VIA SYRINGE AND THE PUMP. THE REPORTED BG EXCURSIONS DO NOT MEET ANIMAS CRITERIA FOR REPORTABILITY. THE FAMILY MEMBER REPORTED THAT THE INFUSION SET SITE WAS CHANGED LAST WEEK, AND THAT THERE WAS WHITE RESIDUE IN THE CARTRIDGE COMPARTMENT AND AT THE LUER CONNECTION OF THE CARTRIDGE/TUBING NOTED WHILE CHANGING THE SITE. THIS COMPLAINT IS BEING REPORTED FOR POSSIBLE LEAKAGE AT THE LUER CONNECTION TO THE CARTRIDGE/TUBING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ANIMAS INSULIN CARTRIDGE INSULIN INFUSION PUMP LZG ANIMAS CORPORATION ANM IR1200/1250/2020/OTP CART

    Patients

    Seq Age Sex Outcome Treatment
    1 10 YR