BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ONETOUCHPING GLUCOSEMGMTSYSTEM

    MDR report key: 3201513 · Received July 2, 2013

    Report

    Report Number
    2531779-2013-09517
    Event Type
    Malfunction
    Date Received
    July 2, 2013
    Report Date
    June 4, 2013
    Manufacturer
    ANIMAS CORPORATION
    Product Code
    LZG
    PMA / PMN Number
    K080639
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NC, US
    Reporter Occupation
    OTHER

    Narratives

    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.

    Additional Manufacturer Narrative · 1

    FOLLOW-UP # 1 DATE OF SUBMISSION 08/20/2013 - DEVICE EVALUATION:THE PUMP HAS BEEN RETURNED AND EVALUATED BY PRODUCT ANALYSIS ON 07/29/2013 WITH THE FOLLOWING FINDINGS: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. DURING TESTING, THE PUMP WAS POWERED ON AND THE SCREEN WAS BLANK. AUDIBLE TONES AND VIBRATORY ALARMS WERE FUNCTIONAL AT STARTUP. THE DISPLAY SCREEN WAS FOUND TO BE CRACKED. WHEN REPLACED WITH A TEST DISPLAY, THE SCREEN FUNCTIONED PROPERLY.

    Description of Event or Problem · 1

    ON (B)(6) 2013, THE REPORTER CONTACTED ANIMAS, ALLEGING A DISPLAY (BLANK SCREEN) ISSUE. AT THE TIME OF TROUBLESHOOTING, THE REPORTER CLAIMED SHE REPLACED THE PUMP'S BATTERY BUT THE DISPLAY ISSUE REMAINED UNRESOLVED. THE REPORTER ALSO CONFIRMED THAT THE PUMP WAS MAKING AUDIBLE NOISES, DESPITE SCREEN BEING BLANK. 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
    301698 ONETOUCHPING GLUCOSEMGMTSYSTEM INSULIN INFUSION PUMP LZG ANIMAS CORPORATION

    Patients

    Seq Age Sex Outcome Treatment
    1 16 YR