BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ANIMAS INSULIN CARTRIDGE

    MDR report key: 3831325 · Received May 24, 2014

    Report

    Report Number
    2531779-2014-14701
    Event Type
    Injury
    Date Received
    May 24, 2014
    Date of Event
    May 15, 2014
    Report Date
    May 16, 2014
    Manufacturer
    ANIMAS CORPORATION
    Product Code
    LZG
    PMA / PMN Number
    K032257
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NC, US
    Reporter Occupation
    PATIENT

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE IS NOT AVAILABLE FOR RETURN TO ANIMAS. IF THE DEVICE IS RETURNED, AN EVALUATION SHALL BE COMPLETED AND A SUPPLEMENTAL REPORT WILL BE FILED. NO CONCLUSION CAN BE MADE AT THIS TIME.

    Additional Manufacturer Narrative · 1

    (B)(4)-DEVICE EVALUATION: A RETAINED CARTRIDGE WAS EVALUATED BY PRODUCT ANALYSIS ON (B)(4) 2014 WITH THE FOLLOWING FINDINGS: A RETAIN SAMPLE FROM THE SAME LOT NUMBER WAS TESTED. NO FAILURES WERE OBSERVED DURING THE CARTRIDGE LOT REVIEW. A VISUAL INSPECTION OF THE CARTRIDGE WAS PERFORMED. NO DAMAGE OR DEFECTS WERE NOTED. A FILL TEST WAS PERFORMED WITH NO FAILURES OBSERVED. A LEAK TEST WAS PERFORMED WITH NO LEAKS OBSERVED; NO FAILURES WERE OBSERVED RELATED TO THE AIR BUBBLE COMPLAINT. THE CARTRIDGE FORCE READINGS WERE CONFIRMED TO BE WITHIN SPECIFICATIONS. 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 THE PATIENT¿S BLOOD GLUCOSE (BG) WAS ABOVE 500 MG/DL WITH LARGE LEVELS OF KETONES AND NAUSEA. IT WAS REPORTED THE PATIENT¿S HEALTH CARE PROVIDER (HCP) RECOMMENDED OVER THE PHONE THAT THE PATIENT¿S INFUSION SITE BE CHANGED AND THE HCP CHANGED THE PUMP¿S BASAL RATES. THE REPORTER STATED THERE WAS EVIDENCE OF AN INSULIN CARTRIDGE LEAK AND AIR BUBBLES WERE PRESENT IN THE INSULIN CARTRIDGE. IT WAS REPORTED THE PATIENT REQUIRED MORE INSULIN DUE TO PUBERTY. THIS COMPLAINT IS BEING REPORTED BASED ON THE ALLEGATION THAT THE PATIENT EXPERIENCED HYPERGLYCEMIA ASSOCIATED WITH AN ALLEGED CARTRIDGE MALFUNCTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    309638 ANIMAS INSULIN CARTRIDGE INSULIN INFUSION PUMP LZG ANIMAS CORPORATION

    Patients

    Seq Age Sex Outcome Treatment
    1 14 YR Life Threatening