BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ONETOUCHPING GLUCOSEMGMTSYSTEM

    MDR report key: 4140733 · Received October 3, 2014

    Report

    Report Number
    2531779-2014-28327
    Event Type
    Malfunction
    Date Received
    October 3, 2014
    Report Date
    September 23, 2014
    Manufacturer
    ANIMAS CORPORATION
    Product Code
    LZG
    PMA / PMN Number
    K080639
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    PATIENT

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE EVALUATION: THE PUMP HAS BEEN RETURNED, AND IT WAS EVALUATED BY PRODUCT ANALYSIS ON 11/26/2014 WITH THE FOLLOWING FINDINGS: THE REPORTED DIM/FADING/COLOR-SPECTRUM DISPLAY ISSUE COULD NOT BE ADEQUATELY INVESTIGATED DUE TO AN UNRELATED BLANK DISPLAY ISSUE; NO CONCLUSIONS COULD BE DETERMINED IN REGARDS TO THE REPORTED ISSUE. THE FOLLOWING FINDINGS ARE UNRELATED TO THE REPORTED ISSUE: THE PUMP POWERED ON, AS CONFIRMED BY THE PRESENCE OF THE AUDITORY AND VIBRATORY CUES; HOWEVER, THE DISPLAY SCREEN WAS BLANK. THE PUMP CASE WAS REMOVED, AND THE DISPLAY SCREEN WAS OBSERVED TO BE DAMAGED; THIS DEVICE FAILURE CAUSED THE BLANK DISPLAY. 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.

    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 (DIM/FADING/COLOR SPECTRUM) ISSUE. REPORTEDLY, THE USER COULD NOT READ THE DISPLAY SCREEN SAFELY. 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
    619897 ONETOUCHPING GLUCOSEMGMTSYSTEM INSULIN INFUSION PUMP LZG ANIMAS CORPORATION

    Patients

    Seq Age Sex Outcome Treatment
    1 9 YR