BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ANIMAS INSULIN CARTRIDGE

    MDR report key: 5854995 · Received August 8, 2016

    Report

    Report Number
    2531779-2016-19484
    Event Type
    Malfunction
    Date Received
    August 8, 2016
    Report Date
    July 15, 2016
    Manufacturer
    ANIMAS CORPORATION
    Product Code
    LZG
    UDI-DI
    10840406100167
    PMA / PMN Number
    K032257
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    PATIENT

    Narratives

    Additional Manufacturer Narrative · 1

    FOLLOW-UP #1: DATE OF SUBMISSION 09/18/2016. DEVICE EVALUATION: THE CARTRIDGE HAS NOT BEEN RETURNED; A RETAIN SAMPLE LOT U200135 WAS PULLED AND EVALUATED BY PRODUCT ANALYSIS ON 08/26/2016 WITH THE FOLLOWING FINDINGS: A VISUAL INSPECTION OF THE CARTRIDGE WAS PERFORMED. NO DAMAGE OR DEFECTS WERE NOTED. THE CARTRIDGE WAS CYCLED AND FILLED SUCCESSFULLY WITH NO AIR BUBBLES FORMED INSIDE THE CARTRIDGE. A CARTRIDGE LEAK TEST WAS PERFORMED AND NO LEAKS WERE NOTED FROM ANYWHERE ON THE CARTRIDGE. A CARTRIDGE FORCE TEST WAS COMPLETED WITH ALL OF THE CARTRIDGE FORCE MEASUREMENTS WITHIN REQUIRED SPECIFICATIONS.

    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. 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. (B)(6).

    Description of Event or Problem · 1

    ON (B)(6) 2016, THE REPORTER CONTACTED ANIMAS, ALLEGING AIR BUBBLES ISSUE WITH THE CARTRIDGE. THERE WAS NO INDICATION THAT THE PRODUCT CAUSED OR CONTRIBUTED TO AN ADVERSE EVENT. THIS ISSUE IS REPORTABLE BECAUSE THE PRESENCE OF AIR BUBBLES OR A LEAK IN THE CARTRIDGE CAN RESULT IN UNDER DELIVERY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    506236 ANIMAS INSULIN CARTRIDGE INSULIN INFUSION PUMP LZG ANIMAS CORPORATION U200135 10840406100167

    Patients

    Seq Age Sex Outcome Treatment
    1