BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ONETOUCHPING GLUCOSEMGMTSYSTEM

    MDR report key: 3252367 · Received July 29, 2013

    Report

    Report Number
    2531779-2013-12021
    Event Type
    Malfunction
    Date Received
    July 29, 2013
    Report Date
    July 5, 2013
    Manufacturer
    ANIMAS CORPORATION
    Product Code
    LZG
    PMA / PMN Number
    K080639
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    PATIENT

    Narratives

    Additional Manufacturer Narrative · 1

    THE PUMP HAS NOT BEEN RETURNED TO ANIMAS. 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.

    Additional Manufacturer Narrative · 1

    THE PUMP HAS BEEN RETURNED AND EVALUATED BY PRODUCT ANALYSIS ON 10/28/2013 WITH THE FOLLOWING FINDINGS: A REVIEW OF THE PUMP¿S HISTORY SHOWED NO ACTIVITY OUTSIDE OF NORMAL USE. THE TIME AND DATE WERE FOUND TO BE MANUALLY MANIPULATED FROM 9:35 PM ON (B)(6) 2013 TO 10:15 AM ON (B)(6) 2013. DURING TESTING, THE PUMP WAS EXERCISED FOR FIVE DAYS WITH NO ALARMS OR TIME ISSUES. THE PUMP WAS FOUND TO BE ABLE TO MAINTAIN TIME AND DATE SETTINGS WITHIN 5 SECONDS AFTER 5 DAYS, AND THE PUMP WAS ABLE TO MAINTAIN THE TIME AND DATE AFTER POWERING OFF FOR 70 MINUTES. UNRELATED TO THE COMPLAINT, EVALUATION REVEALED A DIM AND DISCOLORED DISPLAY SCREEN. A TEST SCREEN WAS INSTALLED AND DISPLAYED PROPERLY. 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.

    Description of Event or Problem · 1

    ON (B)(6) 2013, THE REPORTER CONTACTED ANIMAS, ALLEGING A HISTORY/SETTINGS (TIME/DATE ISSUE) ISSUE. IT WAS REPORTED THAT THE PUMP RANDOMLY CHANGED THE DATE AND TIME ON ITS OWN, AND AM/PM WERE REVERSED. 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
    352914 ONETOUCHPING GLUCOSEMGMTSYSTEM INSULIN INFUSION PUMP LZG ANIMAS CORPORATION

    Patients

    Seq Age Sex Outcome Treatment
    1 22 YR