BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ANIMAS INSULIN CARTRIDGE

    MDR report key: 4063618 · Received September 5, 2014

    Report

    Report Number
    2531779-2014-25248
    Event Type
    Malfunction
    Date Received
    September 5, 2014
    Report Date
    August 22, 2014
    Manufacturer
    ANIMAS CORPORATION
    Product Code
    LZG
    PMA / PMN Number
    K032257
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, 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 SUSPECT DEVICE HAS NOT BEEN RETURNED TO ANIMAS. A RETAINED SAMPLE, FROM THE SAME LOT NUMBER AS THE SUSPECT DEVICE, WAS EVALUATED BY PRODUCT ANALYSIS ON 09/16/2014 WITH THE FOLLOWING FINDINGS: A VISUAL INSPECTION REVEALED THAT THE CARTRIDGE WAS NOT DAMAGED OR DEFECTIVE. A FILL TEST, FORCE TEST, AND LEAK TEST WERE PERFORMED, WITH NO FAILURES OBSERVED. THE CARTRIDGE FORCE READINGS WERE CONFIRMED TO BE WITHIN SPECIFICATIONS; NO FAILURES RELATED TO THE LOSS OF PRIME COMPLAINT WERE NOTED. A LOT REVIEW WAS PERFORMED, WHICH SHOWED THAT NO FAILURES WERE OBSERVED DURING INCOMING INSPECTION. 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 A PRIME (LOSS OF PRIME) ISSUE. IT WAS REPORTED THAT A LOSS OF PRIME WARNING OCCURRED 3 OR MORE TIMES DURING THE USE OF A SINGLE CARTRIDGE. 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
    544998 ANIMAS INSULIN CARTRIDGE INSULIN INFUSION PUMP LZG ANIMAS CORPORATION D200055

    Patients

    Seq Age Sex Outcome Treatment
    1 19 YR