BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ANIMAS INSULIN INFUSION PUMP

    MDR report key: 3873784 · Received June 16, 2014

    Report

    Report Number
    2531779-2014-17059
    Event Type
    Malfunction
    Date Received
    June 16, 2014
    Report Date
    June 11, 2014
    Manufacturer
    ANIMAS CORPORATION
    Product Code
    LZG
    PMA / PMN Number
    K042873
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CT, US
    Reporter Occupation
    PATIENT

    Narratives

    Additional Manufacturer Narrative · 1

    FOLLOW-UP #1: DATE OF SUBMISSION: 12/11/2015. DEVICE EVALUATION: THE DEVICE HAS BEEN RETURNED AND EVALUATED BY PRODUCT ANALYSIS ON 12/01/2015 WITH THE FOLLOWING FINDINGS: A REVIEW OF THE PUMP BLACK BOX REVEALED THAT THE DATA FROM THE DAY OF THE COMPLAINT WAS OVERWRITTEN. THE CURRENT BLACK BOX SHOWED NO EVIDENCE OF A ¿NO POWER¿ ISSUE. THERE WAS EVIDENCE OF MOISTURE CONTAMINATION INSIDE THE BATTERY COMPARTMENT. A LEAK TEST SHOWED A LEAK AT THE BATTERY COMPARTMENT CRACK. THE PUMP CASE WAS REMOVED AND THERE WAS NO EVIDENCE OF ADDITIONAL MOISTURE INSIDE THE PUMP. THE PUMP WAS EXERCISED FOR 24 HOURS WITH NO REBOOT, LOSS OF POWER OR CALL SERVICE ALARMS DUPLICATED. A ¿NO POWER¿ EVENT WAS NOT DUPLICATED DURING THE INVESTIGATION. UNRELATED TO THE ORIGINAL COMPLAINT, THE BATTERY COMPARTMENT WAS FOUND TO BE CRACKED BELOW THE GRIP PAD. 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.

    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 MADE AT THIS TIME.

    Description of Event or Problem · 1

    ON (B)(6) 2014, THE REPORTER CONTACTED ANIMAS, ALLEGING A POWER (MOISTURE INGRESS) ISSUE. THE REPORTER ALLEGED THAT THE PUMP HAD NO POWER. IT WAS NOTED THAT THERE WAS MOISTURE/CORROSION BEHIND THE DISPLAY. THIS COMPLAINT IS BEING REPORTED BECAUSE THE REPORTED ISSUE WAS NOT RESOLVED WITH TROUBLESHOOTING. THERE WAS NO INDICATION THAT THE PRODUCT CAUSED OR CONTRIBUTED TO AN ADVERSE EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    352398 ANIMAS INSULIN INFUSION PUMP INSULIN INFUSION PUMP LZG ANIMAS CORPORATION

    Patients

    Seq Age Sex Outcome Treatment
    1 44 YR