BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ANIMAS INSULIN INFUSION PUMP

    MDR report key: 3030587 · Received April 2, 2013

    Report

    Report Number
    2531779-2013-03411
    Event Type
    Malfunction
    Date Received
    April 2, 2013
    Report Date
    March 7, 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

    FOLLOW-UP #1 DATE OF SUBMISSION (B)(4) 2013 DEVICE EVALUATION: THE PUMP HAS BEEN RETURNED AND EVALUATED BY PRODUCT ANALYSIS ON (B)(4) 2013 WITH THE FOLLOWING FINDINGS: CONFIRMED THE TEXT ON THE DISPLAY SCREEN IS DIM/FADED AND DISCOLORED UPON START UP AND DIFFICULT TO READ. THE CONTRAST SETTING IS SET AT '7'. INVESTIGATORS INCREASED THE CONTRAST SETTING TO THE MAXIMUM OF '10' WITH LITTLE IMPROVEMENT OBSERVED. THE FADED DISPLAY WAS REPLACED WITH TEST DISPLAY. THE TEST SCREEN IS FULLY FUNCTIONAL AND IS FULLY ILLUMINATED WITH NO VISIBLE SIGNS OF FADING OR DISCOLORATION OF TEXT. COMPLETED THE TESTING WITH TEST DISPLAY. INVESTIGATORS OBSERVED NO AUDITORY SOUND DURING START UP. ALL AUDITORY ALARM SETTINGS WERE SET TO ¿HIGH¿ SETTING AND TESTED. NO SOUND DURING TESTING. COVER WAS REMOVED TO INVESTIGATE. NO ISSUE FOUND WITH SOLDER ON PIEZO OR ON THE PIEZO CONTACT PINS. ADJUSTED THE HEIGHT OF THE PIEZO CONTACT PINS. REPLACED COVER AND RE-STARTED PUMP. NO SOUND OCCURRED. PLACED A TEST COVER ON PUMP AND RESTARTED PUMP. SOUND RETURNED WITH TEST COVER. INVESTIGATORS WERE UNABLE TO OBTAIN AN AUDIBLE ALARM READING BECAUSE OF UNRESPONSIVE PIEZO.

    Additional Manufacturer Narrative · 1

    THE PUMP HAS NOT BEEN RETURNED TO ANIMAS. 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. 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)(4).

    Description of Event or Problem · 1

    ON (B)(6) 2013, THE REPORTER CONTACTED ANIMAS ALLEGING THAT THE DISPLAY SCREEN WAS DIM/FADED. THIS COMPLAINT IS BEING REPORTED BECAUSE THE REPORTED ISSUE WAS NOT RESOLVED WITH TROUBLESHOOTING. THERE WAS NO INDICATION THAT THE DEVICE CAUSED OR CONTRIBUTED TO AN ADVERSE EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    134216 ANIMAS INSULIN INFUSION PUMP INSULIN INFUSION PUMP LZG ANIMAS CORPORATION

    Patients

    Seq Age Sex Outcome Treatment
    1