BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ANIMAS INSULIN INFUSION PUMP

    MDR report key: 4101733 · Received September 19, 2014

    Report

    Report Number
    2531779-2014-26818
    Event Type
    Malfunction
    Date Received
    September 19, 2014
    Report Date
    September 8, 2014
    Manufacturer
    ANIMAS CORPORATION
    Product Code
    LZG
    PMA / PMN Number
    K042873
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    PATIENT

    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 MADE AT THIS TIME. (B)(6).

    Additional Manufacturer Narrative · 1

    DEVICE EVALUATION: THE PUMP HAS BEEN RETURNED AND EVALUATED BY PRODUCT ANALYSIS ON 11/10/2014 WITH THE FOLLOWING FINDINGS: DURING TESTING, THE PUMP POWERED ON TO A BLANK DISPLAY WITH AUDIO TONES AND VIBRATIONS FUNCTIONAL. THE DISPLAY WAS FOUND TO BE BLANK DUE TO A FAILED DISPLAY FLEX. THE RETURNED BATTERY CAP WAS ABLE TO BE SECURED TO THE PUMP AND WAS USED TO COMPLETE ALL TESTING. UNRELATED TO THE COMPLAINT, EVALUATION REVEALED THAT THE BATTERY COMPARTMENT WAS CRACKED BELOW THE BUMPER PAD. THE COMPLAINT THAT THE DISPLAY WAS DIM OR FADED WAS NOT ABLE TO BE ADEQUATELY INVESTIGATED DUE TO THE BLANK DISPLAY ISSUE. 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) 2014, THE REPORTER CONTACTED ANIMAS, ALLEGING A DISPLAY (DIM/FADING/COLOR SPECTRUM) ISSUE. THE DISTRIBUTOR ALLEGED THAT THE DISPLAY SCREEN TEXT WAS FADED OR DIM. 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
    583561 ANIMAS INSULIN INFUSION PUMP INSULIN INFUSION PUMP LZG ANIMAS CORPORATION

    Patients

    Seq Age Sex Outcome Treatment
    1