BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ANIMAS INSULIN CARTRIDGE

    MDR report key: 2782129 · Received October 11, 2012

    Report

    Report Number
    2531779-2012-12129
    Event Type
    Injury
    Date Received
    October 11, 2012
    Report Date
    September 13, 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

    THE CARTRIDGE HAS NOT BEEN RETURNED TO ANIMAS FOR EVALUATION. 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) - THE CARTRIDGE WAS NOT RETURNED. A RESERVED SAMPLE FROM THE SAME CARTRIDGE LOT NUMBER B201737 WAS TESTED AND EVALUATED BY PRODUCT ANALYSIS ON (B)(4) 2012 WITH THE FOLLOWING FINDINGS: A VISUAL INSPECTION, A FILL TEST, A FORCE TEST AND A LEAK TEST OF THE CARTRIDGE WERE PERFORMED AND NO DAMAGE OR DEFECTS WERE NOTED. 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 PATIENT CONTACTED ANIMAS ALLEGING THAT A COUPLE OF WEEKS AGO, THE CONNECTION BETWEEN THE CARTRIDGE AND INFUSION SET TUBING BECAME LOOSE TWO OR THREE TIMES AND HER BLOOD GLUCOSE (BG) ELEVATED TO 550MG/DL WITH KETONES. SPECIFIC DATES FOR THE ALLEGED BG EXCURSIONS WERE NOT PROVIDED. THE PATIENT DENIED ANY OTHER SIGNS OR SYMPTOMS OF HYPERGLYCEMIA. THE PATIENT STATED THAT ONCE SHE REALIZED THE CONNECTION WAS NOT SECURE, SHE DISCONNECTED, FIXED THE ISSUE, RECONNECTED, AND CORRECTED FOR ELEVATED BG VIA THE PUMP. AFTER CORRECTION VIA THE PUMP, THE PATIENT'S BGS REPORTEDLY RETURNED TO BETWEEN 105 AND 110MG/DL. THE CARTRIDGE(S) AND INFUSION SET(S) IN QUESTION WERE NOT AVAILABLE FOR TROUBLESHOOTING AT THE TIME OF THE CALL WITH ANIMAS CUSTOMER SUPPORT, AS THE ALLEGED ISSUE HAD OCCURRED A COUPLE OF WEEKS AGO AND THE PATIENT NO LONGER HAD THE PRODUCTS IN QUESTION. THE PATIENT WAS REPORTEDLY STILL USING CARTRIDGES AND INFUSION SETS FROM THE SAME LOTS AS THE LOT SHE EXPERIENCED THE ALLEGED ISSUE WITH, AND HAD NOT HAD ANY FURTHER INCIDENTS. THE PATIENT BELIEVED THE ISSUE WAS CAUSED BY A STRUCTURAL PROBLEM WITH THE PRODUCT(S). ANIMAS DOES NOT MANUFACTURE THE INFUSION SET BUT WILL FORWARD THE COMPLAINT TO THE RELEVANT MANUFACTURER. THIS COMPLAINT IS BEING REPORTED BECAUSE THE PATIENT ALLEGEDLY EXPERIENCED HYPERGLYCEMIA AFTER THE CARTRIDGE BECAME LOOSE FROM THE INFUSION SET TUBING.

    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 B201737

    Patients

    Seq Age Sex Outcome Treatment
    1 23 YR Life Threatening