BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ANIMAS INSULIN CARTRIDGE

    MDR report key: 2173021 · Received July 23, 2011

    Report

    Report Number
    2531779-2011-05135
    Event Type
    Malfunction
    Date Received
    July 23, 2011
    Report Date
    June 23, 2011
    Manufacturer
    ANIMAS CORPORATION
    Product Code
    LZG
    PMA / PMN Number
    K032257
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OR, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). DEVICE EVALUATION: 27 CARTRIDGES WERE RETURNED AND EVALUATED BY PRODUCT ANALYSIS ON (B)(4) 2011 WITH THE FOLLOWING FINDINGS: THE CARTRIDGES PASSED VISUAL INSPECTION, NO DAMAGES OR DEFECTS WERE OBSERVED TO THE LUER CONNECTIONS, O-RINGS, PLUNGERS, OR CARTRIDGE BODY. A FILL TEST WAS COMPLETED WITH NO AIR BUBBLES BEING FORMED INSIDE THE CARTRIDGES. A LEAK TEST WAS PERFORMED WITH NO FAILURES BEING OBSERVED; NO LEAKS WERE OBSERVED FROM THE LUER CONNECTIONS, O-RINGS OR ANYWHERE ELSE IN THE CARTRIDGES. A FORCE TEST WAS PERFORMED AND NO FAILURES WERE FOUND. NO DEFECTS WERE FOUND.

    Additional Manufacturer Narrative · 1

    (B)(6). 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.

    Description of Event or Problem · 1

    A FAMILY MEMBER REPORTED THAT THE PATIENT EXPERIENCED BLOOD GLUCOSE (BG) BETWEEN 400 AND 500 MG/DL AFTER ROUTINE CARTRIDGE CHANGES. A SPECIFIC EVENT DATE WAS NOT PROVIDED. THERE WERE NO REPORTED SIGNS OR SYMPTOMS OF HYPERGLYCEMIA, AND NO REPORTED MEDICAL INTERVENTION. THE REPORTED BG EXCURSION DOES NOT MEET THE DEFINITION OF A SERIOUS INJURY. THE FAMILY MEMBER STATED THAT THREE CARTRIDGES FROM LOT # B201627 WERE LEAKING FROM THE PLUNGER END OF THE CARTRIDGE. HE STATED THAT HE NOTICED THE LEAKING WHEN HE REMOVED THE CARTRIDGE FROM THE PUMP.

    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 B201627

    Patients

    Seq Age Sex Outcome Treatment
    1 6 YR