BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ANIMAS INSULIN CARTRIDGE

    MDR report key: 5596498 · Received April 21, 2016

    Report

    Report Number
    2531779-2016-08280
    Event Type
    Malfunction
    Date Received
    April 21, 2016
    Report Date
    April 6, 2016
    Manufacturer
    ANIMAS CORPORATION
    Product Code
    LZG
    PMA / PMN Number
    K032257
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    PATIENT

    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. 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

    DEVICE EVALUATION: THE CARTRIDGE HAS NOT BEEN RETURNED; A RETAINED SAMPLE FROM THE REPORTED CARTRIDGE LOT NUMBER D200264 WAS PULLED AND EVALUATED BY PRODUCT ANALYSIS 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.

    Description of Event or Problem · 1

    ON (B)(6) 2016, THE REPORTER CONTACTED ANIMAS, ALLEGING A PRIME (LOSS OF PRIME) ISSUE. IT WAS REPORTED THAT THE PUMP EMITTED MULTIPLE LOSS OF PRIME WARNINGS WHILE THE SAME CARTRIDGE WAS IN USE. THIS COMPLAINT IS BEING REPORTED BECAUSE THE REPORTED ISSUE WAS NOT RESOLVED WITH TROUBLESHOOTING. THERE WAS NO INDICATION THAT THE PRODUCT CAUSED OR CONTRIBUTED TO AN ADVERSE EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    249632 ANIMAS INSULIN CARTRIDGE INSULIN INFUSION PUMP LZG ANIMAS CORPORATION D200264

    Patients

    Seq Age Sex Outcome Treatment
    1 67 YR