BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ANIMAS INSULIN CARTRIDGE

    MDR report key: 4100388 · Received September 18, 2014

    Report

    Report Number
    2531779-2014-26713
    Event Type
    Malfunction
    Date Received
    September 18, 2014
    Report Date
    September 3, 2014
    Manufacturer
    ANIMAS CORPORATION
    Product Code
    LZG
    PMA / PMN Number
    K032257
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NC, US
    Reporter Occupation
    PATIENT

    Narratives

    Additional Manufacturer Narrative · 1

    THE CARTRIDGE HAS BEEN RETURNED TO ANIMAS. EVALUATION HAS NOT YET BEEN COMPLETED. WHEN EVALUATION IS COMPLETE 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

    FOLLOW-UP # 1 DATE OF SUBMISSION 10/03/2014 ¿ DEVICE EVALUATION: THE CARTRIDGE HAS BEEN RETURNED AND EVALUATED BY PRODUCT ANALYSIS (B)(4) 2014 WITH THE FOLLOWING FINDINGS: THE CARTRIDGE WAS RETURNED TO ANIMAS. 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 OR FLUID OBSERVED LEAKING OUT AT THE PLUNGER END OF THE CARTRIDGE. 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 SITE/SET/CART (CANNULA/NEEDLE/HOUSING ISSUE) ISSUE. THE REPORTER ALLEGED THAT THE NEEDLE THAT CAME WITH THE CARTRIDGE WAS BLUNT AND UNUSABLE. 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
    580675 ANIMAS INSULIN CARTRIDGE INSULIN INFUSION PUMP LZG ANIMAS CORPORATION D200063

    Patients

    Seq Age Sex Outcome Treatment
    1 51 YR