BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ANIMAS INSULIN INFUSION PUMP

    MDR report key: 2110977 · Received June 2, 2011

    Report

    Report Number
    2531779-2011-03868
    Event Type
    Malfunction
    Date Received
    June 2, 2011
    Report Date
    May 9, 2011
    Manufacturer
    ANIMAS CORPORATION
    Product Code
    LZG
    PMA / PMN Number
    K042873
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TN, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE PUMP HAS BEEN RETURNED TO ANIMAS. EVALUATION HAS NOT YET BEEN COMPLETED. WHEN EVALUATION IS COMPLETE A SUPPLEMENTAL REPORT WILL BE FILED. NO CONCLUSION CAN BE MADE AT THIS TIME.

    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: THE PUMP WAS FOUND TO POWER ON NORMALLY. A REVIEW OF THE PUMP HISTORY INDICATED REBOOTING HAD OCCURRED ON THE DATE OF THE REPORTED ISSUE, BUT COULD NOT BE DUPLICATED DURING TESTING. THE PUMP HISTORY INDICATED THAT THE PUMP WAS IN USE FOR FOUR DAYS AFTER THE REPORTED INCIDENT WITH NO FURTHER POWER ISSUES. THERE WERE NO ALARMS RELATED TO THE COMPLAINT NOTED IN THE ALARM HISTORY. THE PUMP WAS EXERCISED FOR 24 HOURS WITH NO POWER ISSUES OR ALARMS OCCURRING. THE BATTERY CAP SECURED PROPERLY TO THE PUMP, AND THERE WAS NO DAMAGE NOTED TO THE BATTERY CAP, BATTERY COMPARTMENT, OR TO THE POWER CIRCUIT. 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. THERE WAS NO DEFECT FOUND ON INVESTIGATION; THE COMPLAINT COULD NOT BE DUPLICATED.

    Description of Event or Problem · 1

    THE PATIENT REPORTED THAT THE PUMP SELF REBOOT THREE TIMES IN THE EVENING. THE PATIENT STATED THERE IS NO TRAUMA TO THE PUMP AND NO WATER EXPOSURE. THE PATIENT REPORTED SHE SAW THE VERIFY SCREEN.

    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 43 YR