BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ANIMAS INSULIN CARTRIDGE

    MDR report key: 2749429 · Received September 18, 2012

    Report

    Report Number
    2531779-2012-10796
    Event Type
    Injury
    Date Received
    September 18, 2012
    Report Date
    August 21, 2012
    Manufacturer
    ANIMAS CORPORATION
    Product Code
    LZG
    PMA / PMN Number
    K032257
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    VA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    FOLLOW UP #1 SUBMITTED: (B)(4) 2012. DEVICE EVALUATION: A RETAINED CARTRIDGE SAMPLE FROM LOT # B201725 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.

    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.

    Description of Event or Problem · 1

    ON (B)(6) 2012, THE PATIENT CLAIMED HER BLOOD GLUCOSE WAS ELEVATED BETWEEN 300-500 MG/DL DUE TO OCCLUSION ISSUE. DURING TROUBLESHOOTING, THE PATIENT NOTED THE CANNULA WAS KINKED AND BENT AFTER EACH OCCLUSION ISSUE OR HIGH BLOOD GLUCOSE EPISODE. IN ADDITION, THE PATIENT WAS NOT USING THE CARTRIDGE PER THE INSTRUCTION FOR USE (IFU). THE CARTRIDGE ALLEGEDLY WAS NOT CYCLE BEFORE FILLING WITH INSULIN. THIS COMPLAINT IS BEING REPORTED DUE TO POSSIBLE USE ERROR AGAINST THE CARTRIDGE AND BECAUSE THE PATIENT HAD ELEVATED BLOOD GLUCOSE BETWEEN 300-500 MG/DL AFTER THE ONSET OF THE OCCLUSION ISSUE.

    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 B201725

    Patients

    Seq Age Sex Outcome Treatment
    1 84 YR Life Threatening