BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ANIMAS INSULIN CARTRIDGE

    MDR report key: 2261235 · Received September 23, 2011

    Report

    Report Number
    2531779-2011-07037
    Event Type
    Injury
    Date Received
    September 23, 2011
    Date of Event
    September 19, 2011
    Report Date
    September 20, 2011
    Manufacturer
    ANIMAS CORPORATION
    Product Code
    LZG
    PMA / PMN Number
    K032257
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    FOLLOW-UP #1 DATE OF SUBMISSION (B)(6) 2011 DEVICE EVALUATION: A RETAIN CARTRIDGE FROM LOT # 201572 HAS BEEN EVALUATED BY PRODUCT ANALYSIS ON (B)(6) 2011 WITH THE FOLLOWING FINDINGS: A VISUAL INSPECTION OF THE CARTRIDGE WAS PERFORMED. NO DAMAGE OR DEFECTS WERE NOTED. A LEAK 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 FOR EVALUATION. 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. (B)(6).

    Description of Event or Problem · 1

    A FAMILY MEMBER REPORTED THAT THE PATIENT EXPERIENCED A BLOOD GLUCOSE OF 31 MMOL/L. THE FAMILY MEMBER REPORTED THAT THE PATIENT'S BG STARTED ELEVATING ON (B)(6) 2011. THE PUMP REPORTEDLY ALARMED FOR AN EMPTY CARTRIDGE AND THE CARTRIDGE COMPARTMENT WAS WET WITH INSULIN; THE FAMILY MEMBER WAS REPORTEDLY UNSURE IF THE INSULIN WAS COMING FROM THE PLUNGER OR FROM THE LUER CONNECTION. THE CARTRIDGE AND SET WERE CHANGED. ON (B)(6) 2011 DURING A BOLUS, THE FAMILY MEMBER REPORTEDLY NOTICED LEAKING AT THE INFUSION SITE. THE FAMILY MEMBER REPORTED THAT THE SITE WAS REMOVED AND THE CANNULA DID NOT LOOK BENT, THERE WAS NO BLOOD AT THE SITE, AND NO SCAR TISSUE WAS FOUND. THIS REPORT IS MADE BASED ON THE ALLEGATION THAT THE PATIENT EXPERIENCED HYPERGLYCEMIA WHILE USING INSULIN PUMP THERAPY.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 13 YR Required Intervention