BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ANIMAS INSULIN CARTRIDGE

    MDR report key: 2402410 · Received January 6, 2012

    Report

    Report Number
    2531779-2012-00157
    Event Type
    Malfunction
    Date Received
    January 6, 2012
    Report Date
    December 9, 2011
    Manufacturer
    ANIMAS CORPORATION
    Product Code
    LZG
    PMA / PMN Number
    K032257
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE 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.

    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 CARTRIDGE SAMPLE FROM LOT # B201674 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 FILL TEST AND 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.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT STOOD UP AND REALIZED THAT THE INFUSION SET TUBING WAS NOT CONNECTED TO THE CARTRIDGE, AND INSULIN HAD LEAKED OUT OF THE CARTRIDGE. THE PATIENT CONNECTED THE TUBING BACK TO THE CARTRIDGE AND TOOK CORRECTION BOLUSES. NO MORE INSULIN LEAKED AFTER THE TUBING WAS RE-CONNECTED. THE REPORTER INDICATED THAT WHEN ATTACHED THE TUBING-CARTRIDGE CONNECTION LOOKED CROOKED.

    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