BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ANIMAS INSULIN INFUSION PUMP

    MDR report key: 3153131 · Received June 8, 2013

    Report

    Report Number
    2531779-2013-07890
    Event Type
    Malfunction
    Date Received
    June 8, 2013
    Report Date
    May 14, 2013
    Manufacturer
    ANIMAS CORPORATION
    Product Code
    LZG
    PMA / PMN Number
    K042873
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UT, US
    Reporter Occupation
    PATIENT

    Narratives

    Additional Manufacturer Narrative · 1

    THE PUMP HAS NOT BEEN RETURNED TO ANIMAS. 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 #1 DATE OF SUBMISSION (B)(6) 2015 DEVICE EVALUATION: THE DEVICE HAS BEEN RETURNED AND EVALUATED BY PRODUCT ANALYSIS ON (B)(6) 2015 WITH THE FOLLOWING FINDINGS: DURING TESTING, THE PUMP¿S VIBRATORY FEATURE WAS NOT FUNCTIONING. THE PUMP COVER WAS OPENED AND THE VIBRATION MOTOR PINS WERE FOUND TO BE MISALIGNED. THE PINS WERE REALIGNED, AND THE MOTOR FUNCTIONED PROPERLY DURING TESTING. UNRELATED TO THE COMPLAINT, THE DISPLAY SCREEN WAS DIM AND DISCOLORED. THE AUDIO BOLUS BUTTON COVER WAS TORN. THE BUTTON RESPONDED PROPERLY DURING TESTING. THE BATTERY COMPARTMENT WAS CRACKED. EVIDENCE OF MOISTURE CONTAMINATION WAS FOUND IN THE BATTERY COMPARTMENT. THE PUMP PASSED A LEAK TEST AND NO FURTHER MOISTURE INGRESS WAS FOUND IN THE PUMP. 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.

    Description of Event or Problem · 1

    ON (B)(6) 2013, THE REPORTER CONTACTED ANIMAS, ALLEGING A AUDIO TONE/VIBRATION (NO VIBRATION) ISSUE. THE REPORTER STATED THAT THE VIBRATION FEATURE ON THE PUMP WAS NOT WORKING. 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
    256045 ANIMAS INSULIN INFUSION PUMP INSULIN INFUSION PUMP LZG ANIMAS CORPORATION

    Patients

    Seq Age Sex Outcome Treatment
    1 19 YR