BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ANIMAS INSULIN CARTRIDGE

    MDR report key: 2213531 · Received August 16, 2011

    Report

    Report Number
    2531779-2011-05953
    Event Type
    Malfunction
    Date Received
    August 16, 2011
    Report Date
    July 19, 2011
    Manufacturer
    ANIMAS CORPORATION
    Product Code
    LZG
    PMA / PMN Number
    K032257
    Report Source
    Manufacturer report
    Reporter Location
    MO, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

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

    Additional Manufacturer Narrative · 1

    THE CARTRIDGES HAVE BEEN RETURNED TO ANIMAS. EVALUATION IS NOT YET COMPLETE. 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. WHEN EVALUATION IS COMPLETE THE RESULTS WILL BE REPORTED IN A SUPPLEMENTAL REPORT. NO CONCLUSIONS CAN BE MADE AT THIS TIME.

    Description of Event or Problem · 1

    THE PATIENT REPORTED THAT THE INSULIN LEAKED OUT OF THE PLUNGER END OF TWO CARTRIDGES. SHE NOTICED INSULIN IN THE CARTRIDGE COMPARTMENT. SHE SAYS HER BLOOD GLUCOSE LEVEL ELEVATED TO 190 MG/DL WITHOUT NAUSEA, VOMITING, SHORTNESS OF BREATH, OR KETONES. TROUBLESHOOTING CONFIRMED THE PATIENT WAS USING THE CARTRIDGE PER THE IFU. THERE WAS NO REPORTED PATIENT IMPACT ASSOCIATED WITH THIS COMPLAINT.

    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

    Patients

    Seq Age Sex Outcome Treatment
    1 35 YR