BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ANIMAS INSULIN CARTRIDGE

    MDR report key: 2307255 · Received October 25, 2011

    Report

    Report Number
    2531779-2011-07948
    Event Type
    Malfunction
    Date Received
    October 25, 2011
    Report Date
    October 1, 2011
    Manufacturer
    ANIMAS CORPORATION
    Product Code
    LZG
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CO, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). DEVICE EVALUATION: NO CARTRIDGE HAS BEEN RETURNED, A RETAINED SAMPLE WAS PULLED AND EVALUATED BY PRODUCT ANALYSIS ON (B)(4) 2011 WITH THE FOLLOWING FINDINGS: THE CARTRIDGE PASSED VISUAL INSPECTION, NO DAMAGE OR DEFECTS WERE NOTED TO THE LUER CONNECTION OR O-RINGS. A LEAK TEST WAS PERFORMED WITH NO FAILURES BEING OBSERVED; NO LEAKS WERE OBSERVED FROM THE LUER CONNECTION, O-RINGS, OR ANYWHERE ELSE IN THE CARTRIDGE.

    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. THE 510(K) # = K032257.

    Description of Event or Problem · 1

    ON (B)(6), 2011, THE LAY-USER/PATIENT CONTACTED ANIMAS ALLEGING A CARTRIDGE LEAK. THE PATIENT'S FATHER STATED THAT THE PATIENT WAS ORIGINALLY AT A FRIEND'S HOUSE AND RECEIVED AN EXCEEDS MAX TDD ALARM. THE PATIENT REPORTEDLY DISCONNECTED AND TOOK OUT THE CARTRIDGE FROM THE CARTRIDGE COMPARTMENT. THE CARTRIDGE WAS FOUND TO BE WET. THE PATIENT THEN WENT HOME AND HIS FATHER OBSERVED INSULIN IN THE BOTTOM OF THE CARTRIDGE COMPARTMENT. THE PATIENT REPORTEDLY DEVELOPED ELEVATED BLOOD GLUCOSE (BG) LEVELS DURING THE TIME OF CONCERN. THE PATIENT REPORTED ACTUAL RESULTS OF: "376, 374, AND 308 MG/DL." THE REPORTER INDICATED THAT THE CARTRIDGE/TUBING WERE TIGHTENED PROPERLY. BASED ON THE INFORMATION PROVIDED, THIS COMPLAINT IS BEING REPORTED DUE TO THE FOLLOWING CONCLUSION: THE PATIENT CLAIMED THAT HE HAD A CARTRIDGE LEAK. HOWEVER, THERE IS NO EVIDENCE THAT THE DEVICE CONTRIBUTED TO A SERIOUS INJURY. THE PATIENT DID NOT REPORT ANY BLOOD GLUCOSE READINGS, SYMPTOMS, OR TREATMENT THAT MEET ANIMAS' CRITERIA FOR A SERIOUS INJURY.

    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 15 YR