BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ANIMAS INSULIN CARTRIDGE

    MDR report key: 4192532 · Received October 22, 2014

    Report

    Report Number
    2531779-2014-29933
    Event Type
    Injury
    Date Received
    October 22, 2014
    Report Date
    October 7, 2014
    Manufacturer
    ANIMAS CORPORATION
    Product Code
    LZG
    PMA / PMN Number
    K032257
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NC, US
    Reporter Occupation
    PATIENT

    Narratives

    Additional Manufacturer Narrative · 1

    THE CARTRIDGE HAS NOT BEEN REQUESTED FOR RETURN 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) 2014, THE REPORTER CONTACTED ANIMAS, ALLEGING THAT THE PATIENT EXPERIENCED HYPERGLYCEMIA ASSOCIATED WITH A REPEATED LOSS OF PRIME ISSUE. REPORTEDLY, ON AN UNSPECIFIED DATE, THE PATIENT¿S BLOOD GLUCOSE (BG) READING WAS AT 427 MG/DL WITH FREQUENT URINATION, ATYPICAL THIRST, MUSCULAR TIGHTNESS AND SYMPTOM OF DEHYDRATION. IT WAS REPORTED THAT THE PATIENT DID NOT RECEIVE ANY TREATMENT ABOVE AND BEYOND THE USUAL ROUTINE OF DIABETES CARE AND MANAGEMENT. THE PATIENT ALLEGEDLY REMAINED ON PUMP THERAPY WITHOUT ANY RECENT ADJUSTMENT TO THE PUMP SETTINGS. CUSTOMER TECHNICAL SUPPORT AGENT REVIEWED THE EVENT WITH THE REPORTER. IT WAS REPORTED THAT THE PUMP ALERTED FOR LOSS OF PRIME MULTIPLE TIMES SINCE ABOUT A WEEK AGO. THE REPORTER WAS ABLE TO COMPLETE PRIME STEP WITH CARTRIDGE CHANGE. NO SUDDEN CHANGE IN FORCE OR TEMPERATURE WAS NOTED AND THE CARTRIDGE CAP WAS SECURED PROPERLY. REVIEW OF CARTRIDGE USE TECHNIQUES INDICATED THAT THE INSTRUCTION FOR USE (IFU) WAS NOT BEING FOLLOWED. THIS COMPLAINT IS BEING REPORTED BASED ON THE ALLEGATION THAT THE PATIENT EXPERIENCED SEVERE HYPERGLYCEMIA ASSOCIATED WITH A USE ERROR IN THAT THE IFU FOR CARTRIDGE USE WAS NOT BEING FOLLOWED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    672809 ANIMAS INSULIN CARTRIDGE INSULIN PUMP CARTRIDGE LZG ANIMAS CORPORATION

    Patients

    Seq Age Sex Outcome Treatment
    1 44 YR Life Threatening