BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ANIMAS INSULIN CARTRIDGE

    MDR report key: 3052701 · Received April 11, 2013

    Report

    Report Number
    2531779-2013-04066
    Event Type
    Malfunction
    Date Received
    April 11, 2013
    Report Date
    March 15, 2013
    Manufacturer
    ANIMAS CORPORATION
    Product Code
    LZG
    PMA / PMN Number
    K032257
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WI, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    FOLLOW-UP #1 DATE OF SUBMISSION 06/26/2013-DEVICE EVALUATION: THE CARTRIDGE WAS RETURNED AND EVALUATED BY PRODUCT ANALYSIS ON 06/12/2013 WITH THE FOLLOWING FINDINGS:A VISUAL INSPECTION OF THE CARTRIDGE WAS PERFORMED. NO DAMAGE OR DEFECTS WERE NOTED. A LEAK TEST WAS PERFORMED WITH NO FAILURES OBSERVED. A RETAIN CARTRIDGE SAMPLE FROM THE SAME LOT WAS ALSO TESTED, WITH NO FAILURES OBSERVED. 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 HAS NOT BEEN RETURNED TO ANIMAS. 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.

    Description of Event or Problem · 1

    ON (B)(6) 2013, THE REPORTER CONTACTED ANIMAS, ALLEGING A SITE/SET/CART (CARTRIDGE LEAK) ISSUE. THE PATIENT STATED THAT SHE HAD EXPERIENCED HIGHER THAN NORMAL BLOOD GLUCOSE (BG) BUT DENIED SYMPTOMS AND DID NOT PROVIDE ANY BG VALUES. THE PATIENT NOTED THAT THE CARTRIDGE WAS RUNNING OUT OF INSULIN SOONER THAN IT SHOULD. THE CARTRIDGE COMPARTMENT IS REPORTEDLY DRY BUT SMELLS LIKE INSULIN. THIS COMPLAINT IS BEING REPORTED BECAUSE THE REPORTED ISSUE WAS NOT RESOLVED WITH TROUBLESHOOTING. THE REPORTED BG EXCURSIONS DO NOT MEET CRITERIA FOR A SERIOUS INJURY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    155509 ANIMAS INSULIN CARTRIDGE INSULIN PUMP CARTRIDGE LZG ANIMAS CORPORATION B201936

    Patients

    Seq Age Sex Outcome Treatment
    1 53 YR