BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ANIMAS INSULIN CARTRIDGE

    MDR report key: 2904535 · Received January 9, 2013

    Report

    Report Number
    2531779-2013-00433
    Event Type
    Injury
    Date Received
    January 9, 2013
    Date of Event
    December 12, 2012
    Report Date
    December 13, 2012
    Manufacturer
    ANIMAS CORPORATION
    Product Code
    LZG
    PMA / PMN Number
    K032257
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    VA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    CUSTOMER TECHNICAL SUPPORT DETERMINED THAT THE LOSS OF PRIME WAS DUE TO AN ISSUE WITH THE CARTRIDGE. THE PUMP WAS FOUND TO BE ALARMING APPROPRIATELY TO ALERT THE USER OF AN ISSUE. THE OWNER'S BOOKLET INSTRUCTS THE USER TO BE PREPARED TO GIVE HIS OR HERSELF AN INJECTION OF INSULIN IF DELIVERY IS INTERRUPTED FOR ANY REASON. 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

    FOLLOW-UP #2 DATE OF SUBMISSION (B)(4) 2013-DEVICE EVALUATION: THE CARTRIDGE HAS BEEN RETURNED AND EVALUATED BY PRODUCT ANALYSIS ON (B)(4) 2013 WITH THE FOLLOWING FINDINGS: A VISUAL INSPECTION OF THE CARTRIDGE WAS PERFORMED. NO DAMAGE OR DEFECTS WERE NOTED. A LEAK TEST, FORCE TEST, AND FILL 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. THIS REPORT IS MADE UNDER THE REQUIREMENTS OF THE MEDICAL DEVICE REPORTING REGULATIONS AND DOES NOT CONSTITUTE AN ADMISSION ON THE PART OF ANIMAS OF ANY DEFICIENCY IN THE PERFORMANCE OF THE DEVICE.

    Additional Manufacturer Narrative · 1

    FOLLOW UP #1 SUBMITTED: (B)(4) 2013 - NO PRODUCT WAS RETURNED FOR DISPOSITION. A RETAINED CARTRIDGE SAMPLE FROM LOT # B201895 WAS EVALUATED. A VISUAL INSPECTION OF THE CARTRIDGE WAS PERFORMED. NO DAMAGE OR DEFECTS WERE NOTED. A LEAK TEST, FILL TEST, AND FORCE 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.

    Description of Event or Problem · 1

    ON (B)(6) 2012 THE REPORTER CONTACTED ANIMAS ALLEGING THAT ON THE NIGHT OF (B)(6) 2012 THE PATIENT EXPERIENCED ELEVATED BLOOD GLUCOSE (BG) OF 400MG/DL WITH MILD NAUSEA, EXCESSIVE URINATION, AND KETONES DUE TO LOSS OF PRIME WARNINGS THAT OCCURRED WITH THE PATIENT WAS SLEEPING. THE REPORTER STATED THAT THE PATIENT'S BG WAS CORRECTED VIA THE PUMP, AND HIS BG RESOLVED TO 180MG/DL THE MORNING OF (B)(6) 2012. THE REPORTER CONFIRMED THAT THE CARTRIDGE CAP WAS SECURE. THE REPORTER CONFIRMED PROPER TECHNIQUE IN CARTRIDGE USE, AND DENIED ANY ISSUES WITH TEMPERATURE OR FORCE. DURING TROUBLESHOOTING, THE REPORTER WAS ABLE TO SUCCESSFULLY PRIME INTO THE AIR AND THE PUMP HELD PRIME. CUSTOMER TECHNICAL SUPPORT ADVISED THE REPORTER TO CHANGE THE CARTRIDGE AND TO CONTACT ANIMAS IF ADDITIONAL ALARMS OCCUR. THIS COMPLAINT IS BEING REPORTED DUE TO THE ALLEGATION THAT THE PATIENT EXPERIENCED HYPERGLYCEMIA WHILE USING INSULIN PUMP THERAPY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    12913 ANIMAS INSULIN CARTRIDGE INSULIN PUMP CARTRIDGE LZG ANIMAS CORPORATION ANM IR1200/1250/2020/OTP CART

    Patients

    Seq Age Sex Outcome Treatment
    1 14 YR Life Threatening