BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ANIMAS INSULIN INFUSION PUMP

    MDR report key: 3941444 · Received July 17, 2014

    Report

    Report Number
    2531779-2014-20419
    Event Type
    Malfunction
    Date Received
    July 17, 2014
    Report Date
    July 1, 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 BEEN RETURNED AND EVALUATED BY PRODUCT ANALYSIS ON 08/11/2014 WITH THE FOLLOWING FINDINGS: DURING TESTING, THE DISPLAY WAS FOUND TO BE DIM, FADING, AND DISCOLORED. THERE WERE NO LINES THROUGH THE DISPLAY OBSERVED. UNRELATED TO THE COMPLAINT, EVALUATION REVEALED THAT THE BATTERY COMPARTMENT WAS CRACKED BELOW THE FINGER PAD. NO CARTRIDGE OR BATTERY CAPS WERE RETURNED WITH THE PUMP. A TEST BATTERY CAP WAS USED TO COMPLETE ALL TESTING. THE COMPLAINT THAT THERE WERE LINES THROUGH THE DISPLAY WAS NO ABLE TO BE DUPLICATED DURING INVESTIGATION.

    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 DISPLAY (LINE THROUGH DISPLAY) ISSUE. THE REPORTER ALLEGED THAT THERE WERE LINES THROUGH THE DISPLAY SCREEN. 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
    418109 ANIMAS INSULIN INFUSION PUMP INSULIN INFUSION PUMP LZG ANIMAS CORPORATION

    Patients

    Seq Age Sex Outcome Treatment
    1