BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ANIMAS INSULIN CARTRIDGE

    MDR report key: 3053519 · Received April 11, 2013

    Report

    Report Number
    2531779-2013-04083
    Event Type
    Injury
    Date Received
    April 11, 2013
    Date of Event
    April 6, 2013
    Report Date
    April 6, 2013
    Manufacturer
    ANIMAS CORPORATION
    Product Code
    LZG
    PMA / PMN Number
    K032257
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    OTHER

    Narratives

    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.

    Additional Manufacturer Narrative · 1

    (B)(4) - DEVICE EVALUATION: THE PUMP HAS BEEN RETURNED AND EVALUATED BY PRODUCT ANALYSIS ON (B)(4) 2013 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 WAS PERFORMED WITH NO FAILURES OBSERVED. EACH CARTRIDGE LOT IS SUBJECTED TO A STATISTICAL SAMPLING PLAN AND MUST PASS TESTING FOR FORCE, CRACKS, AND FOREIGN MATERIAL PRIOR TO RELEASE FOR DISTRIBUTION.

    Description of Event or Problem · 1

    THE PATIENT CONTACTED ANIMAS ON (B)(4) 2013 REPORTING BLOOD GLUCOSE LEVELS UP TO 32.2 MMOL/L WITH INCREASED THIRST, VOMITING, AND UPSET STOMACH. THE PATIENT REPORTED THAT AFTER MULTIPLE SITE CHANGES, BLOOD GLUCOSE LEVELS WERE DOWN TO 25.4 MMOL/L . THE PATIENT REPORTED THAT UPON WAKING IN THE MORNING, THE TUBING WAS FOUND TO BE DISCONNECTED FROM THE CARTRIDGE. THE PUMP PRIME HISTORY INDICATED THAT THE LAST SITE CHANGE WAS TWO NIGHTS PRIOR. THE PATIENT CONFIRMED THAT THE LUER CONNECTION WAS NOT BROKEN AND THE CARTRIDGE AND TUBING WERE WORKING FOR SOME TIME PRIOR TO BECOMING DISCONNECTED. THE PATIENT CONFIRMED THAT THE CONNECTION WAS TIGHT WHEN THE CARTRIDGE WAS PLACED INTO THE PUMP. THIS REPORT IS MADE BASED ON THE ALLEGATION THAT THE PATIENT EXPERIENCED HYPERGLYCEMIA RELATED TO THE LUER CONNECTION BECOMING DISCONNECTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    156111 ANIMAS INSULIN CARTRIDGE INSULIN INFUSION PUMP LZG ANIMAS CORPORATION

    Patients

    Seq Age Sex Outcome Treatment
    1 67 YR Life Threatening