BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    OTHER

    MDR report key: 2074204 · Received May 2, 2011

    Report

    Report Number
    2531779-2011-03030
    Event Type
    Malfunction
    Date Received
    May 2, 2011
    Date of Event
    April 4, 2011
    Report Date
    April 4, 2011
    Manufacturer
    ANIMAS CORPORATION
    Product Code
    LZG
    PMA / PMN Number
    K032257
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KY, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    AFTER THE EVALUATION IS COMPLETED AND A SUPPLEMENTAL REPORT WILL BE FILLED. NO CONCLUSIONS CAN BE DRAWN AT THIS TIME. THE REPORT IS UNDER THE REQUIREMENTS OF THE MEDICAL DEVICE REPORTING REGULATIONS AND DOES NOT CONSTITUTE AN ADMISSION ON THE PART OF ANIMAS OF ANY DEFICIENCY IN THE PERFORMANCE OF THE DEVICE. (B)(4)

    Additional Manufacturer Narrative · 1

    FOLLOW-UP # 1 (B)(6) 2011 - DEVICE EVALUATION: THE CARTRIDGE HAS NOT BEEN RETURNED TO ANIMAS; A RETAINED SAMPLE WAS EVALUATED BY PRODUCT ANALYSIS ON (B)(6) 2011 WITH THE FOLLOWING FINDINGS: THE CARTRIDGE PASSES VISUAL INSPECTION; THERE IS 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. THIS CARTRIDGE OF LOT B 201532 IS NOT PART OF THE CARTRIDGE RECALL.

    Description of Event or Problem · 1

    THE REPORTER CLAIMED THAT THE ANIMAS CARTRIDGE IS LEAKING AT THE PLUNGER END. REPORTEDLY, THERE WERE NO VISIBLE CRACKS. THE LEUR LOCK WAS SECURE AND DRY. THE PATIENT DID NOT HAVE ANY SYMPTOMS OR MEDICAL INTERVENTION THAT WOULD SUGGEST A SERIOUS INJURY. THIS COMPLAINT IS BEING REPORTED AS A MALFUNCTION DUE TO THE ALLEGED CARTRIDGE LEAKAGE ISSUE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 OTHER INSULIN INFUSION PUMP LZG ANIMAS CORPORATION ANM IR1200/1250/2020/OTP CART 201532

    Patients

    Seq Age Sex Outcome Treatment
    1 29 YR