BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ANIMAS INSULIN INFUSION PUMP

    MDR report key: 2003094 · Received February 8, 2011

    Report

    Report Number
    2531779-2011-00695
    Event Type
    Malfunction
    Date Received
    February 8, 2011
    Date of Event
    January 8, 2011
    Report Date
    January 8, 2011
    Manufacturer
    ANIMAS CORPORATION
    Product Code
    LZG
    PMA / PMN Number
    K032257
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    RI, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THERE IS NO ADVERSE EVENT ASSOCIATED WITH THIS COMPLAINT. THE CARTRIDGE HAS BEEN RETURNED TO ANIMAS. EVALUATION HAS NOT YET BEEN COMPLETED. WHEN EVALUATION IS COMPLETE A SUPPLEMENTAL REPORT WILL BE FILED. A RESERVED SAMPLE FROM THE SAME LOT NUMBER WAS TESTED. A VISUAL INSPECTION OF THE CARTRIDGE WAS PERFORMED. NO DAMAGE OR DEFECTS WERE NOTED. A LEAK TEST WAS PERFORMED WITH NO FAILURES OBSERVED. EACH CARTRIDGE LOT IS SUBJECTED TO A STATISTICAL SAMPLING PLAN AND MUST PASS TESTING FOR FORCE (OCCLUSION AND LOSS OF PRIME), CRACKS, AND FOREIGN MATERIAL PRIOR TO RELEASE FOR DISTRIBUTION.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT INSULIN LEAKED INTO THE CARTRIDGE COMPARTMENT. THE PATIENT NOTED THAT THE CARTRIDGE COMPARTMENT APPEARED TO BE WET. HE SAID THAT HE COULD NOT DETECT THE LOCATION OF THE LEAK. THE LUER LOCK CONNECTION TO THE TUBING WAS CONFIRMED TO BE SECURE. THERE WAS NO VISIBLE DAMAGE TO THE TUBING AND NO CRACKS IN THE CARTRIDGE, AND THE THREE BLACK O-RINGS ON THE CARTRIDGE ARE INTACT. THE PATIENT REPORTED THAT HE DRIED THE COMPARTMENT WITH A COTTON SWAB AND COMPLETED THE REWIND, LOAD CARTRIDGE, AND PRIME STEPS WITHOUT DIFFICULTY OR FURTHER LEAKAGE NOTED. HE DENIED BLOOD GLUCOSE EXCURSION DUE TO THE LEAKAGE; HE REPORTED HIS BLOOD GLUCOSE WAS 238MG/DL AT THE TIME OF THE EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ANIMAS INSULIN INFUSION PUMP INSULIN INFUSION PUMP LZG ANIMAS CORPORATION IR 1200/1250/2020/OTP B201581

    Patients

    Seq Age Sex Outcome Treatment
    1 40 YR