BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ANIMAS INSULIN CARTRIDGE

    MDR report key: 3174730 · Received June 18, 2013

    Report

    Report Number
    2531779-2013-08404
    Event Type
    Malfunction
    Date Received
    June 18, 2013
    Date of Event
    May 21, 2013
    Report Date
    May 27, 2013
    Manufacturer
    ANIMAS CORPORATION
    Product Code
    LZG
    PMA / PMN Number
    K032257
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(6). THE INSULIN CARTRIDGES HAVE NOT BEEN RETURNED TO ANIMAS. 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. IF THE DEVICES ARE RETURNED, AN EVALUATION SHALL BE COMPLETED AND A SUPPLEMENTAL REPORT WILL BE FILED. NO CONCLUSIONS CAN BE MADE AT THIS TIME.

    Additional Manufacturer Narrative · 1

    FOLLOW UP #1 SUBMITTED: 08/09/2013DEVICE EVALUATION: THE CARTRIDGE WAS RETURNED TO ANIMAS. A VISUAL INSPECTION OF THE CARTRIDGE WAS PERFORMED. NO DAMAGE OR DEFECTS WERE NOTED. A LEAK TEST WAS PERFORMED WITH NO FAILURES OBSERVED. THERE WAS NO FLUID OBSERVED LEAKING OUT AT THE PLUNGER END OF THE CARTRIDGE. FILL TEST WAS COMPLETED WITH NO AIR BUBBLES BEING FORMED INSIDE THE CARTRIDGE; THE CARTRIDGE CYCLED NORMALLY AND NO DIFFICULTIES WERE FOUND FILLING 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

    THE DISTRIBUTOR CONTACTED ANIMAS ON (B)(6) 2013 ALLEGING THAT THE PISTON WAS VERY HARD TO MOVE WHEN IN CONTACT WITH THE INSULIN CARTRIDGE. THE DISTRIBUTOR STATED THIS HAS ONLY HAPPENED WITH CARTRIDGES FROM LOT # B201777. THE DISTRIBUTOR ALSO REPORTED THAT THE PATIENT STATED SHE BELIEVED SHE COULD ALSO SEE AIR BUBBLES FORMED INSIDE THE INSULIN CARTRIDGE, WHICH ALLEGEDLY CAUSED HYPERGLYCEMIA OF AN UNREPORTED MEASUREMENT AND WITH NO REPORTED SYMPTOMS SUGGESTIVE OF HYPERGLYCEMIA. THERE WAS INSUFFICIENT INFORMATION PROVIDED TO SUGGEST THERE WAS A REPORTABLE ADVERSE EVENT ASSOCIATED WITH THIS COMPLAINT. THIS COMPLAINT IS BEING REPORTED BECAUSE THE ALLEGED CARTRIDGE ISSUES REMAINED UNRESOLVED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    274905 ANIMAS INSULIN CARTRIDGE INSULIN PUMP CARTRIDGE LZG ANIMAS CORPORATION B201777

    Patients

    Seq Age Sex Outcome Treatment
    1