BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ANIMAS INSULIN CARTRIDGE

    MDR report key: 2347494 · Received November 23, 2011

    Report

    Report Number
    2531779-2011-08823
    Event Type
    Injury
    Date Received
    November 23, 2011
    Date of Event
    November 13, 2011
    Report Date
    November 14, 2011
    Manufacturer
    ANIMAS CORPORATION
    Product Code
    LZG
    PMA / PMN Number
    K032257
    Adverse Event
    Yes
    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

    OUTCOME SHOULD BE "LIFE-THREATENING."

    Additional Manufacturer Narrative · 1

    (B)(4). DEVICE EVALUATION: THE CARTRIDGE HAS NOT BEEN RETURNED FOR INVESTIGATION. A RETAIN CARTRIDGE SAMPLE FROM LOT # B201692 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. 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)(6) 2011 SHE EXPERIENCED BLOOD GLUCOSE (BG) UP TO 32 MMOL/L WITH NAUSEA. THE PATIENT STATED THAT HER BG ELEVATED TO 14 MMOL/L THE MORNING OF (B)(6) 2011, AND SHE CHANGED HER SITE TWICE BUT HER BG CONTINUED TO ELEVATE. SHE STATED THAT SHE THEN ADMINISTERED A CORRECTION INJECTION AND HER BG RESPONDED. THE PATIENT STATED THAT SHE ATTEMPTED TO CHANGE THE CARTRIDGE WHEN HER BG DID NOT RESPOND TO TWO SITE CHANGES, AND NOTED A SMELL OF INSULIN IN THE CARTRIDGE COMPARTMENT. DURING TROUBLESHOOTING, THE PATIENT MANUALLY PUSHED THE CARTRIDGE PLUNGER AND COULD SEE INSULIN LEAKING AT THE LUER LOCK. THIS COMPLAINT IS BEING REPORTED BECAUSE THE PATIENT ALLEGEDLY EXPERIENCED HYPERGLYCEMIA DUE TO A CARTRIDGE LEAK.

    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 24 YR Life Threatening