BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    OTHER

    MDR report key: 2071071 · Received April 27, 2011

    Report

    Report Number
    2531779-2011-02929
    Event Type
    Malfunction
    Date Received
    April 27, 2011
    Date of Event
    March 29, 2011
    Report Date
    March 29, 2011
    Manufacturer
    ANIMAS CORPORATION
    Product Code
    LZG
    PMA / PMN Number
    K032257
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TN, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    FOLLOW-UP # 1 06/07/2011 - DEVICE EVALUATION: THE CARTRIDGES HAVE BEEN RETURNED AND EVALUATED BY PRODUCT ANALYSIS ON 06/07/2011 WITH THE FOLLOWING FINDINGS: CARTRIDGES WERE RETURNED FROM LOT#'S B201617 & B201627. 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, OR ANYWHERE ELSE IN THE CARTRIDGES.

    Additional Manufacturer Narrative · 1

    BRAND NAME: CARTRIDGE. LOT #:B201627. 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 DRAWN AT THIS TIME.

    Description of Event or Problem · 1

    THE REPORTER REPORTED THE PATIENT NOTED THE INSULIN CARTRIDGE WAS LEAKING AND THE PUMP AND CARTRIDGE WERE WET. ON (B)(6) 2011 THE PATIENT OBTAINED BLOOD GLUCOSE READINGS THAT WERE HIGHER THAN EXPECTED, SUCH AS 254 MG/DL. THE PATIENT EXPERIENCED THE SYMPTOMS OF FEELING TIRED AND "OUT OF IT"; SHE TESTED NEGATIVE FOR KETONES AND EXPERIENCED NO SYMPTOMS SUGGESTING SEVERE HYPERGLYCEMIA. THE PATIENT CONTACTED HER PHYSICIAN FOR ASSISTANCE/ADVICE, AND WAS ADVISED TO MONITOR HER BLOOD GLUCOSE LEVELS AND CONTACT ANIMAS; SHE RECEIVED NO TREATMENT. TROUBLESHOOTING REVEALED THERE WAS NO DAMAGE TO THE CARTRIDGE OR TUBING AND NO CRACKS IN THE PUMP CASING; THE TUBING WAS SECURE TO THE CARTRIDGE LUER LOCK.

    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

    Patients

    Seq Age Sex Outcome Treatment
    1 26 YR