BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ONETOUCHPING GLUCOSEMGMTSYSTEM

    MDR report key: 3230207 · Received July 16, 2013

    Report

    Report Number
    2531779-2013-10998
    Event Type
    Malfunction
    Date Received
    July 16, 2013
    Report Date
    July 2, 2013
    Manufacturer
    ANIMAS CORPORATION
    Product Code
    LZG
    PMA / PMN Number
    K080639
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OR, US
    Reporter Occupation
    OTHER

    Narratives

    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 T HIS TIME.

    Additional Manufacturer Narrative · 1

    THE DEVICE HAS BEEN RETURNED AND EVALUATED BY PRODUCT ANALYSIS ON 09/17/2013 WITH THE FOLLOWING FINDINGS: BLANK DISPLAY SCREEN COULD NOT BE DUPLICATED AND WAS FOUND TO BE FULLY FUNCTIONAL WITH NO VISIBLE SIGNS OF FADING OR DISCOLORATION. TWO BATTERY COMPARTMENT CRACKS WERE OBSERVED IN THREAD AREA. THERE WAS EVIDENCE OF MOISTURE CONTAMINATION IN BATTERY COMPARTMENT OBSERVED. A LEAK TEST INDICATED A LEAK AT THE BATTERY COMPARTMENT CRACK. 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 THAT IF THEY PUSHED DOWN ON THE BATTERY CAP THE DEVICE WOULD MAKE NOISE AND VIBRATE, BUT PRODUCED A BLANK SCREEN. 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
    329788 ONETOUCHPING GLUCOSEMGMTSYSTEM INSULIN INFUSION PUMP LZG ANIMAS CORPORATION

    Patients

    Seq Age Sex Outcome Treatment
    1 37 YR