BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ONETOUCHPING GLUCOSEMGMTSYSTEM

    MDR report key: 3160239 · Received June 10, 2013

    Report

    Report Number
    2531779-2013-08035
    Event Type
    Malfunction
    Date Received
    June 10, 2013
    Report Date
    May 16, 2013
    Manufacturer
    ANIMAS CORPORATION
    Product Code
    LZG
    PMA / PMN Number
    K080639
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MD, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    FOLLOW-UP #1 DATE OF SUBMISSION 08/14/2013-DEVICE EVALUATION: THE PUMP HAS BEEN RETURNED AND EVALUATED BY PRODUCT ANALYSIS ON 07/17/2013 WITH THE FOLLOWING FINDINGS: THE PUMP BOOTS WITH TWO AUDIBLE BEEPS AND VIBRATORY SOUNDS. AFTER APPROXIMATELY FIVE MINUTES THE DISPLAY SCREEN SHOWS A CALL SERVICE SLEEP ERROR MESSAGE. THE DISPLAY SCREEN IS FULLY ILLUMINATED AND HAS NORMAL CONTRAST BUT IS UNABLE TO GO TO THE VERIFY SCREEN DUE TO SLEEP ERROR MESSAGE. THE PUMP THEN WAS ABLE TO GO TO VERIFY SCREEN. THERE WAS NO DEFECT FOUND. THE DISPLAY LENS WAS FOUND TO BE SCRATCHED.

    Additional Manufacturer Narrative · 1

    THE PUMP HAS BEEN RETURNED TO ANIMAS FOR EVALUATION; HOWEVER, PRODUCT INVESTIGATION HAS NOT BEEN COMPLETED. ONCE EVALUATION HAS BEEN COMPLETED, A SUPPLEMENTAL REPORT WILL BE FILED. NO CONCLUSIONS CAN BE MADE AT THIS TIME.

    Description of Event or Problem · 1

    ON (B)(6) 2013, THE REPORTER CONTACTED ANIMAS, ALLEGING A DISPLAY (BLANK SCREEN) ISSUE. THE DISPLAY ON THE ANIMAS PUMP REPORTEDLY IS BLANK AFTER RECEIVING A CALL SERVICE SLEEP ERROR. THE BACKLIGHT WILL NOT LIGHT UP. THE SUBJECT PUMP HAD NOT BEEN USED FOR 7 MONTHS. THE ISSUE WAS DISCOVERED WHEN THE BATTERY WAS REPLACED. THERE WAS NO TRAUMA OR MOISTURE ISSUE. THE PUMP IS BEING RETURNED FOR INVESTIGATION. THERE IS NO INDICATION THAT THE PRODUCT ISSUE CAUSED OR CONTRIBUTED TO AN ADVERSE EVENT. THIS COMPLAINT IS BEING REPORTED BECAUSE THE ISSUE REMAINED UNRESOLVED AT THE TIME OF TROUBLESHOOTING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    260741 ONETOUCHPING GLUCOSEMGMTSYSTEM INSULIN INFUSION PUMP LZG ANIMAS CORPORATION

    Patients

    Seq Age Sex Outcome Treatment
    1 57 YR