BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ANIMAS INSULIN INFUSION PUMP

    MDR report key: 3200973 · Received July 2, 2013

    Report

    Report Number
    2531779-2013-09463
    Event Type
    Malfunction
    Date Received
    July 2, 2013
    Date of Event
    May 22, 2013
    Report Date
    June 5, 2013
    Manufacturer
    ANIMAS CORPORATION
    Product Code
    LZG
    PMA / PMN Number
    K042873
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE EVALUATION: ON EXAMINATION, THE AUDIO BOLUS BUTTON WAS MISSING. THE PUMP POWERED ON WITH AUDITORY TONES; HOWEVER, THE MISSING AUDIO BOLUS BUTTON PREVENTED SOUND LEVEL TESTING. UNRELATED TO THE COMPLAINT, THE DISPLAY WAS NOTED TO BE DIM AND DISCOLORED. A TEST DISPLAY WAS ATTACHED TO THE PUMP AND ILLUMINATED PROPERLY AND WAS CLEARLY LEGIBLE.

    Additional Manufacturer Narrative · 1

    (B)(6). THE PUMP HAS BEEN RETURNED TO ANIMAS BUT EVALUATION HAS NOT YET BEEN COMPLETED. WHEN EVALUATION IS COMPLETE A SUPPLEMENTAL REPORT WILL BE FILED. NO CONCLUSION CAN BE MADE AT THIS TIME.

    Description of Event or Problem · 1

    ON (B)(6) 2013, THE REPORTER CONTACTED ANIMAS, ALLEGING A BUTTON/KEYPAD (ABB MISSING/PEELING/TORN) ISSUE; THE AUDIO BOLUS BUTTON ALLEGEDLY FELL OFF. 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
    303531 ANIMAS INSULIN INFUSION PUMP INSULIN INFUSION PUMP LZG ANIMAS CORPORATION

    Patients

    Seq Age Sex Outcome Treatment
    1