BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ONETOUCHPING GLUCOSEMGMTSYSTEM

    MDR report key: 3911930 · Received July 3, 2014

    Report

    Report Number
    2531779-2014-19021
    Event Type
    Malfunction
    Date Received
    July 3, 2014
    Report Date
    June 28, 2014
    Manufacturer
    ANIMAS CORPORATION
    Product Code
    LZG
    PMA / PMN Number
    K080639
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    RI, US
    Reporter Occupation
    PATIENT

    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

    THE PUMP HAS BEEN RETURNED AND EVALUATED BY PRODUCT ANALYSIS ON 08/15/2014 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. VISUAL INSPECTION OF THE PUMP FOUND SOME COSMETIC DAMAGES. THE PUMP POWERED UP TO A BLANK DISPLAY WITH AUDITORY AND VIBRATORY FEATURES. FUNCTIONAL TESTING FOR THE BUTTONS WAS NOT PERFORMED DUE TO THE BLANK DISPLAY. THE BATTERY COMPARTMENT WAS FOUND TO HAVE CRACKED AT THE THREADS. A LEAK TEST SHOWED A LEAK WHERE THE CRACK WAS LOCATED. PUMP CASING WAS OPENED AND EVIDENCE OF MOISTURE INTRUSION WAS FOUND ON THE DISPLAY AS WELL AS THE DISPLAY CONNECTOR WIRE. REPLACING THE DISPLAY WITH A TEST DISPLAY CORRECTED THE DISPLAY ISSUE. THE REPORTED DISPLAY AND MOISTURE INGRESS ISSUE WAS DUPLICATED IN THE INVESTIGATION.

    Description of Event or Problem · 1

    ON (B)(6) 2014, THE REPORTER CONTACTED ANIMAS, ALLEGING THAT THE DISPLAY WAS BLANK AND THERE WAS MOISTURE IN THE BATTERY COMPARTMENT. IT WAS REPORTED THAT THE ISSUE WAS NOT RESOLVED WITH PUMP REBOOT OR CONTRAST RESET. 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
    390134 ONETOUCHPING GLUCOSEMGMTSYSTEM INSULIN INFUSION PUMP LZG ANIMAS CORPORATION

    Patients

    Seq Age Sex Outcome Treatment
    1 59 YR