BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ANIMAS INSULIN CARTRIDGE

    MDR report key: 2300496 · Received October 19, 2011

    Report

    Report Number
    2531779-2011-07766
    Event Type
    Malfunction
    Date Received
    October 19, 2011
    Date of Event
    September 21, 2011
    Report Date
    September 23, 2011
    Manufacturer
    ANIMAS CORPORATION
    Product Code
    LZG
    PMA / PMN Number
    K032257
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    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). DEVICE EVALUATION: A RETAIN CARTRIDGE FROM LOT # 201572 HAS BEEN EVALUATED BY PRODUCT ANALYSIS ON (B)(4) 2011 WITH THE FOLLOWING FINDINGS: A VISUAL INSPECTION OF THE CARTRIDGE WAS PERFORMED. NO DAMAGE OR DEFECTS WERE NOTED. A LEAK 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 PATIENT REPORTED THAT ON (B)(4) 2011, SHE EXPERIENCED BLOOD GLUCOSE (BG) OF 21 MMOL/L WITH NO SIGNS OR SYMPTOMS OF HYPERGLYCEMIA. SHE STATED THAT WHILE TROUBLESHOOTING TO DETERMINE THE CAUSE OF THE ELEVATED BG, SHE NOTED INSULIN IN THE CARTRIDGE COMPARTMENT AND THAT THE CARTRIDGE WAS LEAKING. THE PATIENT STATED THAT SHE FILLED AND INSERTED A NEW CARTRIDGE AND ADMINISTERED A CORRECTION BOLUS; SHE REPORTEDLY CONTINUED ON INSULIN PUMP THERAPY WITHOUT ANY FURTHER ISSUES. THE PATIENT WAS UNABLE TO PROVIDE DETAILS REGARDING HOW LONG THE LEAKING CARTRIDGE HAD BEEN IN THE PUMP PRIOR TO NOTICING THE LEAK OR IF THERE WAS VISIBLE DAMAGE TO THE CARTRIDGE OR NOT. THE REPORTED BG EXCURSION DOES NOT MEET THE DEFINITION OF A SERIOUS INJURY. THIS COMPLAINT IS BEING REPORTED DUE TO THE ALLEGED CARTRIDGE LEAK, AS A LEAKING CARTRIDGE CAN RESULT IN UNDER-DELIVERY OF INSULIN.

    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 B201572

    Patients

    Seq Age Sex Outcome Treatment
    1 52 YR