BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ANIMAS INSULIN INFUSION PUMP

    MDR report key: 2071945 · Received April 28, 2011

    Report

    Report Number
    2531779-2011-02962
    Event Type
    Malfunction
    Date Received
    April 28, 2011
    Date of Event
    March 30, 2011
    Report Date
    March 30, 2011
    Manufacturer
    ANIMAS CORPORATION
    Product Code
    LZG
    PMA / PMN Number
    K042873
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE PUMP 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.

    Additional Manufacturer Narrative · 1

    ANIMAS HAS CONDUCTED A REVIEW OF THE DEVICE HISTORY RECORD ON (B)(4) 2011 FOR THIS PUMP AND CONFIRMED THAT IT WAS OPERATING WITHIN REQUIRED SPECIFICATIONS AT THE TIME OF RELEASE.

    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: A REVIEW OF THE PUMP HISTORY INDICATED THAT REBOOTING HAD OCCURRED WHICH WAS DUPLICATED DURING TESTING. THERE WAS NO DAMAGE OBSERVED TO THE BATTERY COMPARTMENT. EVALUATION REVEALED THAT THE BATTERY CAP THREADS WERE STRIPPED; THE BATTERY CAP WAS UNABLE TO MAINTAIN AN ELECTRICAL CONNECTION, RESULTING IN REBOOTING. A TEST BATTERY CAP WAS USED TO COMPLETE INVESTIGATION; THE PUMP POWERED ON NORMALLY WITH NO ALARMS. WITH THE TEST CAP, THE PUMP WAS EXERCISED FOR 24 HOURS WITH NO POWER ISSUES OCCURRING. UNRELATED TO THE COMPLAINT, EVALUATION REVEALED A DIM DISPLAY SCREEN, WHICH HAS NO EFFECT ON INSULIN DELIVERY FUNCTION. THE OWNER'S BOOKLET INSTRUCTS THE USER TO CALL ANIMAS CUSTOMER SERVICE IF THE USER SUSPECTS THAT THE PRODUCT IS DAMAGED.

    Description of Event or Problem · 1

    THE REPORTER, THE PATIENT'S MOTHER, REPORTED FOR SEVERAL MONTHS THE PUMP HAD SELF-REBOOTED AND THE PATIENT HAD TO CONFIRM THE VERIFY SCREEN ON THE DISPLAY. THE PATIENT DID NOT EXPERIENCE ANY SYMPTOMS OF HIGH OR LOW BLOOD GLUCOSE LEVELS DURING THIS TIME PERIOD. TROUBLESHOOTING REVEALED THERE WERE NO CRACKS OR DAMAGE IN THE BATTERY COMPARTMENT, THE BATTERY CAP WAS INTACT AND SECURE AND THERE HAD BEEN NO TRAUMA TO THE PUMP. THERE WAS NO ADVERSE EVENT ASSOCIATED WITH THIS ISSUE.

    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 10 YR