BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ANIMAS INSULIN INFUSION PUMP

    MDR report key: 4767438 · Received May 12, 2015

    Report

    Report Number
    2531779-2015-15814
    Event Type
    Malfunction
    Date Received
    May 12, 2015
    Report Date
    April 22, 2015
    Manufacturer
    ANIMAS CORPORATION
    Product Code
    LZG
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SC, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE PUMP HAS NOT BEEN RETURNED TO ANIMAS AT THE TIME OF THIS REPORT. IF THE DEVICE IS RETURNED, AN EVALUATION SHALL BE COMPLETED AND A SUPPLEMENTAL REPORT WILL BE FILED. NO CONCLUSIONS CAN BE MADE AT THIS TIME.

    Additional Manufacturer Narrative · 1

    FOLLOW UP #2 07/09/2015 DEVICE EVALUATION: THE PUMP HAS BEEN RETURNED TO ANIMAS AND EVALUATED ON 06/24/2015 WITH THE FOLLOWING FINDINGS: THE BLACK BOX DATA FROM DATE OF THE ALLEGED EVENT HAS BEEN OVERWRITTEN DUE TO CONTINUED USE OF THE PUMP. PUMP REBOOT EVENTS WERE OBSERVED IN THE BLACK BOX ON 05/04/2015. THERE WAS EVIDENCE OF MOISTURE CONTAMINATION ON THE BATTERY CAP CONTACT HUB. THERE WERE BATTERY COMPARTMENT CRACKS OBSERVED IN THE THREAD AREA AND BELOW THE GRIP PAD. THE PUMP WAS EXERCISED FOR 24 HOURS WITH NO REBOOT, LOSS OF POWER OR CALL SERVICE ALARMS DUPLICATED. AN INTERMITTENT POWER EVENT WAS NOT DUPLICATED DURING THE INVESTIGATION. THE PUMP FAILED A LEAK TEST DUE TO A LEAK AT THE BATTERY COMPARTMENT CRACK. 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 EVIDENCE OF MOISTURE CONTAMINATION OBSERVED INSIDE THE PUMP.

    Additional Manufacturer Narrative · 1

    FOLLOW UP #1 05/13/2015 CORRECTION: THE 510K NUMBER FOR THIS PRODUCT IS K042873.

    Description of Event or Problem · 1

    ON (B)(6) 2015, A REPORTER CONTACTED ANIMAS ALLEGING THAT THERE WAS AN INTERMITTENT POWER ISSUE. THIS COMPLAINT IS BEING REPORTED BECAUSE THE REPORTED ISSUE WAS NOT RESOLVED THROUGH TROUBLESHOOTING. THERE WAS NO ALLEGATION OF AN ADVERSE EVENT ASSOCIATED WITH THIS COMPLAINT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    311058 ANIMAS INSULIN INFUSION PUMP INSULIN INFUSION PUMP LZG ANIMAS CORPORATION

    Patients

    Seq Age Sex Outcome Treatment
    1 35 YR