BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ANIMAS INSULIN CARTRIDGE

    MDR report key: 3082706 · Received April 29, 2013

    Report

    Report Number
    2531779-2013-05502
    Event Type
    Malfunction
    Date Received
    April 29, 2013
    Report Date
    April 1, 2013
    Manufacturer
    ANIMAS CORPORATION
    Product Code
    LZG
    PMA / PMN Number
    K032257
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    FOLLOW-UP #1 DATE OF SUBMISSION (B)(4) 2013 DEVICE EVALUATION: THE PUMP HAS BEEN RETURNED AND EVALUATED BY PRODUCT ANALYSIS ON (B)(4) 2013 WITH THE FOLLOWING FINDINGS: A RESERVED SAMPLE FROM THE SAME LOT NUMBER WAS TESTED. A VISUAL INSPECTION OF THE CARTRIDGE WAS PERFORMED WITH NO DAMAGE OR DEFECTS NOTED. A LEAK TEST WAS PERFORMED 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 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.

    Description of Event or Problem · 1

    THE REPORTER CONTACTED ANIMAS ON (B)(6) 2013 REPORTING THAT THREE TIMES IN THREE WEEKS THERE HAS BEEN SEDIMENT IN THE TUBING. THE NANNY CHANGED OUT THE SITE/SET THIS AM AND NOTICED RIGHT AFTER PRIMING THE TUBING (BEFORE INSERTING INFUSION SET) ALREADY HAD WHITE SEDIMENT IN THE TUBING. DENIED SEEING ANY IN THE CARTRIDGE. THE REPORTER LOOKED AT THE TUBING AND THER WAS WHITE SEDIMENT AT THE HUB OF THE INFUSION SET AND SCATTERED THROUGH THE TUBING. THE REPORTER STATED (PER PREVIOUS CALL) THAT THE ISSUE WAS WITH THE INSULIN, THAT THE TUBING AND CARTRIDGE IS A NON REACTION. THE REPORTER TOOK THE OTHER VIALS BACK TO PHARMACY AND THEY WERE REPLACED LAST WEEK. THE REPORTER STATED THAT THE BG WAS NORMAL. THIS REPORT IS BEING MADE DUE THE CARTRIDGE ISSUE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    185942 ANIMAS INSULIN CARTRIDGE INSULIN INFUSION PUMP LZG ANIMAS CORPORATION B201855

    Patients

    Seq Age Sex Outcome Treatment
    1 5 YR