BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ONETOUCHPING GLUCOSEMGMTSYSTEM

    MDR report key: 4890396 · Received July 5, 2015

    Report

    Report Number
    2531779-2015-22165
    Event Type
    Malfunction
    Date Received
    July 5, 2015
    Report Date
    June 20, 2015
    Manufacturer
    ANIMAS CORPORATION
    Product Code
    LZG
    PMA / PMN Number
    K080639
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TN, US
    Reporter Occupation
    PATIENT

    Narratives

    Additional Manufacturer Narrative · 1

    FOLLOW-UP #1: DATE OF SUBMISSION 07/21/2015. DEVICE EVALUATION: THE DEVICE HAS BEEN RETURNED AND EVALUATED BY PRODUCT ANALYSIS ON 07/07/2015 WITH THE FOLLOWING FINDINGS: THE UP, DOWN, AND OK BUTTONS WERE INTERMITTENTLY UNRESPONSIVE. CONTAMINATION WAS NOT FOUND ON THE BUTTON CONTACTS, BUT MOISTURE DAMAGE WAS FOUND TO THE KEYPAD CONNECTOR. UNRELATED TO THE INITIAL ALLEGATION, THE DISPLAY SCREEN WAS DIM A ND DISCOLORED. THE BATTERY COMPARTMENT WAS FOUND TO BE CRACKED.

    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) 2015, A REPORTER CONTACTED ANIMAS ALLEGING THAT THE UP, DOWN, AND OK BUTTONS WERE UNDERRESPONSIVE. 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
    434244 ONETOUCHPING GLUCOSEMGMTSYSTEM INSULIN INFUSION PUMP LZG ANIMAS CORPORATION

    Patients

    Seq Age Sex Outcome Treatment
    1 11 YR