BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ANIMAS INSULIN CARTRIDGE

    MDR report key: 2402834 · Received January 6, 2012

    Report

    Report Number
    2531779-2012-00165
    Event Type
    Malfunction
    Date Received
    January 6, 2012
    Report Date
    December 11, 2011
    Manufacturer
    ANIMAS CORPORATION
    Product Code
    LZG
    PMA / PMN Number
    K032257
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    ID, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE PUMP HAS NOT BEEN RETURNED TO ANIMAS FOR EVALUATION. ANIMAS HAS CONDUCTED A REVIEW OF THE DEVICE HISTORY RECORD FOR THIS PUMP AND CONFIRMED THAT IT WAS OPERATING WITHIN REQUIRED SPECIFICATIONS AT THE TIME OF RELEASE. 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

    FOLLOW-UP #1 DATE OF SUBMISSION (B)(4) 2012-DEVICE EVALUATION: THE CARTRIDGE HAS NOT BEEN RETURNED FOR INVESTIGATION. A RETAIN SAMPLE FROM LOT # B201701 HAS BEEN EVALUATED BY PRODUCT ANALYSIS ON (B)(4) 2012 WITH THE FOLLOWING FINDINGS: A VISUAL INSPECTION OF THE CARTRIDGE WAS PERFORMED. NO DAMAGE OR DEFECTS WERE NOTED. A LEAK TEST AND A FILL TEST WERE 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.

    Description of Event or Problem · 1

    THIS COMPLAINT IS BEING REPORTED BECAUSE, THE PATIENT CLAIMED THE ANIMAS CARTRIDGE IS LEAKING INSULIN. ON (B)(6) 2011, THE PATIENT SMELLED A STRONG ODOR OF INSULIN UPON CHANGING THE CARTRIDGE AND INFUSION SET. THE PATIENT REPORTEDLY DID NOT IDENTIFY ANY LEAK, DAMAGE OR WETNESS IN THE CARTRIDGE CHAMBER. REPORTEDLY, THE PATIENT CHANGED OUT THE CARTRIDGE 3 MORE TIMES AT NIGHT DUE TO THE CS ALARM. THERE WAS NO PATIENT IMPACT ASSOCIATED WITH THE ALLEGED ISSUE.

    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 B201701

    Patients

    Seq Age Sex Outcome Treatment
    1 66 YR