BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ANIMAS INSULIN CARTRIDGE

    MDR report key: 2425580 · Received January 23, 2012

    Report

    Report Number
    2531779-2012-00560
    Event Type
    Injury
    Date Received
    January 23, 2012
    Report Date
    December 27, 2011
    Manufacturer
    ANIMAS CORPORATION
    Product Code
    LZG
    PMA / PMN Number
    K032257
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE PUMP HAS NOT BEEN RETURNED TO ANIMAS FOR EVALUATION. ANIMAS HAS CONDUCTED A REVIEW OF THE DEVICE HISTORY RECORD FOR THIS PUMP AND CONFIRMED THAT IT WAS OPERATING WITHIN REQUIRED SPECIFICATIONS AT THE TIME OF RELEASE. 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: A RETAIN CARTRIDGE SAMPLE FROM LOT # B201685 HAS BEEN EVALUATED BY PRODUCT ANALYSIS ON (B)(4) 2012 WITH THE FOLLOWING FINDINGS: A VISUAL INSPECTION OF THE CARTRIDGE WAS PERFORMED. NO DAMAGE OR DEFECTS WERE NOTED. LEAK, FILL, AND FORCE TESTS WERE 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 PATIENT ALLEGED THAT HER BLOOD GLUCOSE HAS BEEN ELEVATED FROM 300-600 MG/DL WHILE SHE HAD ISSUES WITH A LEAKING CARTRIDGE ISSUE POSSIBLY DUE TO USER ERROR. THE PATIENT REPORTEDLY WAS REUSING THE CARTRIDGE AND TUBING 4 TIMES BEFORE CHANGING THEM WHICH WAS CONTRARY TO THE MANUFACTURE'S RECOMMENDATION. ON (B)(6) 2011, THE DAY OF THE CALL, THE PATIENT WAS ABLE TO CORRECT HER BLOOD GLUCOSE FROM 592 MG/DL TO 300 MG/DL WITH INSULIN VIA SYRINGE. THE ANIMAS REPRESENTATIVE INFORMED THE PATIENT THAT THE CARTRIDGE AND TUBING CAN ONLY BE USED FOR 3 DAYS THEN REPLACE. THIS COMPLAINT IS BEING REPORTED DUE TO POSSIBLE USER ERROR AND BECAUSE, THE PATIENT CLAIMED SHE HAD HYPERGLYCEMIA OF OVER 500 MG/DL AND REQUIRED TREATMENT.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 62 YR Life Threatening| R