BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ANIMAS INSULIN CARTRIDGE

    MDR report key: 2535683 · Received April 13, 2012

    Report

    Report Number
    2531779-2012-03144
    Event Type
    Malfunction
    Date Received
    April 13, 2012
    Report Date
    March 16, 2012
    Manufacturer
    ANIMAS CORPORATION
    Product Code
    LZG
    PMA / PMN Number
    K032257
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    LOT # B201765.THE CARTRIDGES HAVE 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 06/06/2012-DEVICE EVALUATION: A RETAIN CARTRIDGE SAMPLE FROM LOT # B201765 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. THERE WAS NO DEFECT FOUND ON INVESTIGATION. 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

    THE PATIENT CALLED ANIMAS ON (B)(6) ALLEGING THERE WERE AIR BUBBLES IN THE CARTRIDGE THE SECOND DAY AFTER FILLING THE CARTRIDGE. THE PATIENT STATES THIS HAS BEEN HAPPENING WITH THE LAST TWO SHIPMENT OF CARTRIDGES. THE CARTRIDGE WAS NO EXPIRED AND THE INSULIN WAS NOT EXPIRED. TROUBLESHOOTING DETERMINED THAT THE PATIENT FOLLOWS THE INSTRUCTIONS FOR FILLING THE CARTRIDGE AND CORRECTLY USES ROOM TEMPERATURE INSULIN. THE LUER LOCK OF THE CARTRIDGE TO THE INFUSION SET WAS TIGHT PER THE PATIENT. THIS COMPLAINT IS BEING REPORTED BECAUSE THE PATIENT ALLEGED THAT AIR BUBBLES FORMED IN THE CARTRIDGE. THERE WAS NO REPORTED PATIENT IMPACT ASSOCIATED WITH THIS COMPLAINT.

    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 55 YR