BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ANIMAS INSULIN CARTRIDGE

    MDR report key: 2180645 · Received July 27, 2011

    Report

    Report Number
    2531779-2011-05352
    Event Type
    Malfunction
    Date Received
    July 27, 2011
    Report Date
    June 30, 2011
    Manufacturer
    ANIMAS CORPORATION
    Product Code
    LZG
    PMA / PMN Number
    K032257
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). DEVICE EVALUATION WAS COMPLETED ON ON (B)(4) 2011 WITH THE FOLLOWING FINDINGS: THE CARTRIDGE WAS NOT RETURNED TO ANIMAS. THERE IS NO INVESTIGATION NECESSARY. CARTRIDGES OF LOT # B201581 WERE CONFIRMED TO BE DEFECTIVE. WHEN TESTED, FLUID WAS OBSERVED LEAKING FROM THE PLUNGER END OF 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.

    Description of Event or Problem · 1

    A FAMILY MEMBER REPORTED THAT THE PATIENT HAD LEAKING CARTRIDGES WITH BLOOD GLUCOSE EXCURSIONS BUT THE FAMILY MEMBER DID NOT KNOW ANY SPECIFIC DETAILS. NO FURTHER INFORMATION IS AVAILABLE. ATTEMPTS TO FOLLOW-UP WITH THE PATIENT WERE UNSUCCESSFUL. THIS REPORT IS MADE BASED ON THE ALLEGATION THAT THE INSULIN CARTRIDGE MALFUNCTIONED.

    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 21 YR