BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ANIMAS INSULIN INFUSION PUMP

    MDR report key: 2242057 · Received September 9, 2011

    Report

    Report Number
    2531779-2011-06707
    Event Type
    Malfunction
    Date Received
    September 9, 2011
    Report Date
    August 15, 2011
    Manufacturer
    ANIMAS CORPORATION
    Product Code
    LZG
    PMA / PMN Number
    K042873
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MD, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). DEVICE EVALUATION: THE PUMP HAS BEEN RETURNED AND EVALUATED BY PRODUCT ANALYSIS ON (B)(4) 2011 WITH THE FOLLOWING FINDINGS: DURING EVALUATION CONTAMINATION WAS FOUND ON THE FORCE SENSOR AND THE FORCE SENSOR WAS FOUND TO BE OUT OF CALIBRATION. DURING TESTING, THE PUMP LOAD STEP WAS UNABLE TO DETECT THE FILLED CARTRIDGE.

    Additional Manufacturer Narrative · 1

    RECALL #: 2531779-03/24/2010/003-R. THE PUMP HAS BEEN RETURNED TO ANIMAS. EVALUATION IS NOT YET COMPLETE. WHEN EVALUATION IS COMPLETE, THE RESULTS WILL BE PROVIDED IN A SUPPLEMENTAL REPORT. ANIMAS HAS CONDUCTED A REVIEW OF THE DEVICE HISTORY RECORD FOR THIS PUMP AND CONFIRMED THAT IT WAS OPERATING WITHIN REQUIRED SPECIFICATIONS AT THE TIME OF RELEASE. THE OWNER'S BOOKLET STATES: "NEVER PRIME TUBING OR TIGHTEN THE CARTRIDGE CAP WHILE THE INFUSION SET IS CONNECTED TO YOUR BODY. DOING SO WHILE THE INFUSION SET IS CONNECTED TO YOUR BODY CAN RESULT IN UNINTENDED DELIVERY OF INSULIN, WHICH CAN RESULT IN SERIOUS INJURY OR DEATH."

    Description of Event or Problem · 1

    THE PATIENT REPORTED THAT HE WAS ATTACHED TO THE PUMP DURING A CARTRIDGE CHANGE AND THE PUMP DISPENSED INSULIN FROM THE CARTRIDGE DURING THE LOAD STEP. THE CARTRIDGE WAS FILLED WITH 200 UNITS OF INSULIN AND THE PATIENT REPORTS ABOUT ¾ OF THE INSULIN WAS EMPTIED INTO HIS BODY BEFORE HE PULLED THE SITE OUT OF HIS BODY. THE PATIENT REPORTEDLY LOST CONSCIOUSNESS AND HIS WIFE CALLED EMERGENCY SERVICES. THE PATIENT WAS TAKEN TO THE EMERGENCY ROOM AND HIS BLOOD GLUCOSE READING REGISTERED 20 MG/DL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ANIMAS INSULIN INFUSION PUMP INSULIN INFUSION PUMP LZG ANIMAS CORPORATION ANM 2020 INSULIN INFUSION PUMP

    Patients

    Seq Age Sex Outcome Treatment
    1 55 YR Hospitalization| L| R