BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ANIMAS INSULIN CARTRIDGE

    MDR report key: 2807820 · Received October 29, 2012

    Report

    Report Number
    2531779-2012-12869
    Event Type
    Injury
    Date Received
    October 29, 2012
    Report Date
    October 7, 2012
    Manufacturer
    ANIMAS CORPORATION
    Product Code
    LZG
    PMA / PMN Number
    K032257
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE CARTRIDGE HAS NOT BEEN RETURNED TO ANIMAS FOR EVALUATION. EACH CARTRIDGE LOT IS SUBJECT TO A STATISTICAL SAMPLING PLAN AND MUST PASS TESTING FOR FORCE3 (OCCLUSION AND LOSS OF PRIME), CRACKS, AND FOREIGN MATERIAL PRIOR TO RELEASE FOR DISTRIBUTION.

    Additional Manufacturer Narrative · 1

    FOLLOW UP #1 SUBMITTED: (B)(4) 2012. DEVICE EVALUATION: A RETAINED CARTRIDGE SAMPLE FROM LOT # B201778 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

    THE REPORTER CONTACTED ANIMAS ON (B)(6) 2012 ALLEGING THAT SHE WAS UNABLE TO PRIME THE PUMP. THE REPORTER STATED THAT THE PATIENT EXPERIENCED ELEVATED BLOOD GLUCOSE THAT DAY OF 500 MG/DL WITHOUT KETONES OR SYMPTOMS SUGGESTIVE OF HYPERGLYCEMIA. THE PATIENT'S ELEVATED BG WAS CORRECTED WITHOUT INTERVENTION FROM MEDICAL PERSONNEL. DURING TROUBLESHOOTING WITH ANIMAS CUSTOMER SUPPORT, THE REPORTER WAS INSTRUCTED TO CHANGE OUT THE CARTRIDGE AND THE TUBING AND ATTEMPT THE PRIME AGAIN. WITH THE CHANGE OF THE CARTRIDGE AND TUBING, THE REPORTER WAS ABLE TO SUCCESSFULLY PRIME THE PUMP. THE REPORTED ISSUE OF NOT BEING ABLE TO PRIME THE PUMP IS GENERALLY OBVIOUS AND DETECTABLE BY THE USER. THEREFORE THE DETECTABLE FLAW MAY PREVENT THE USER FROM CONTINUING USE OF THE DEVICE OR CAUSE A CONDITION THAT MAKES CONTINUED USE OF THE DEVICE IMPOSSIBLE. THE OWNER'S BOOKLET INSTRUCTS THE USER TO CALL ANIMAS CUSTOMER SERVICE IF THE USER SUSPECTS THAT THE PRODUCT IS DAMAGED. THIS COMPLAINT IS BEING REPORTED BECAUSE THE PATIENT REPORTEDLY EXPERIENCED ELEVATED BG WHILE USING INSULIN PUMP THERAPY.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 12 YR