BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ANIMAS INSULIN CARTRIDGE

    MDR report key: 3962663 · Received July 29, 2014

    Report

    Report Number
    2531779-2014-21639
    Event Type
    Malfunction
    Date Received
    July 29, 2014
    Report Date
    July 17, 2014
    Manufacturer
    ANIMAS CORPORATION
    Product Code
    LZG
    PMA / PMN Number
    K032257
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    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

    THE CARTRIDGE WAS NOT RETURNED FOR INVESTIGATION. A RESERVED SAMPLE FROM THE SAME LOT NUMBER B201983 WAS EVALUATED AND TESTED BY PRODUCT ANALYSIS ON 08/13/2014 WITH THE FOLLOWING FINDINGS: A VISUAL INSPECTION OF THE CARTRIDGE WAS PERFORMED WITH NO DAMAGE OR DEFECTS NOTED. A FILL TEST WAS COMPLETED WITH NO AIR BUBBLES BEING FORMED INSIDE THE CARTRIDGE. THE CARTRIDGE CYCLED NORMALLY; NO DIFFICULTIES WERE FOUND WITH FILLING THE CARTRIDGE. A LEAK TEST WAS PERFORMED WITH NO FAILURES OBSERVED; NO LEAKS WERE OBSERVED FROM THE LUER CONNECTION, O-RINGS OR ANYWHERE ELSE IN THE CARTRIDGE. THE CARTRIDGE ALSO PASSED THE FORCE TEST. 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

    ON (B)(6) 2014, THE REPORTER CONTACTED ANIMAS, ALLEGING THAT THERE WERE AIR BUBBLES IN THE CARTRIDGE. THE REPORTER CONFIRMED APPROPRIATE CARTRIDGE USE TECHNIQUE WAS BEING USED. 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
    441537 ANIMAS INSULIN CARTRIDGE INSULIN INFUSION PUMP LZG ANIMAS CORPORATION B201983

    Patients

    Seq Age Sex Outcome Treatment
    1