BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ONETOUCHPING GLUCOSEMGMTSYSTEM

    MDR report key: 4183307 · Received October 17, 2014

    Report

    Report Number
    2531779-2014-29658
    Event Type
    Malfunction
    Date Received
    October 17, 2014
    Report Date
    October 7, 2014
    Manufacturer
    ANIMAS CORPORATION
    Product Code
    LZG
    PMA / PMN Number
    K080639
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    PATIENT

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE EVALUATION: THE PUMP HAS BEEN RETURNED AND EVALUATED BY PRODUCT ANALYSIS ON (B)(4) 2014 WITH THE FOLLOWING FINDINGS: VISUAL INSPECTION REVEALED THAT THE PUMP CASE WAS FULLY INTACT; NO EVIDENCE OF PHYSICAL DAMAGE WAS OBSERVED. UNRELATED TO THE COMPLAINT, EVALUATION REVEALED THAT THE DISPLAY WAS DIM/FADED AND THE DISPLAY TEXT WAS DISCOLORED. THE COMPLAINT THAT THE PUMP CASE WAS DAMAGED WAS NOT ABLE TO BE CONFIRMED DURING INVESTIGATION.

    Additional Manufacturer Narrative · 1

    THE PUMP HAS NOT BEEN RETURNED TO ANIMAS AT THE TIME OF THIS REPORT. 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, A REPORTER CONTACTED ANIMAS ALLEGING THAT THERE WAS DAMAGE TO THE PUMP'S CASING. THIS COMPLAINT IS BEING REPORTED BECAUSE THE REPORTED ISSUE WAS NOT RESOLVED THROUGH TROUBLESHOOTING. THERE WAS NO ALLEGATION OF AN ADVERSE EVENT ASSOCIATED WITH THIS COMPLAINT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    660171 ONETOUCHPING GLUCOSEMGMTSYSTEM INSULIN INFUSION PUMP LZG ANIMAS CORPORATION

    Patients

    Seq Age Sex Outcome Treatment
    1 63 YR