BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ONETOUCHPING GLUCOSEMGMTSYSTEM

    MDR report key: 3162429 · Received June 11, 2013

    Report

    Report Number
    2531779-2013-08075
    Event Type
    Malfunction
    Date Received
    June 11, 2013
    Report Date
    May 17, 2013
    Manufacturer
    ANIMAS CORPORATION
    Product Code
    LZG
    PMA / PMN Number
    K080639
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    FOLLOW-UP # 1 DATE OF SUBMISSION 08/06/2013 - DEVICE EVALUATION: THE PUMP HAS BEEN RETURNED AND EVALUATED BY PRODUCT ANALYSIS ON 07/15/2013 WITH THE FOLLOWING FINDINGS: DURING INVESTIGATION, THE PUMP HAD VISIBLE MOISTURE IN THE DISPLAY LENS. THE PUMP POWERED ON TO THE VERIFY SCREEN WITH AUDIBLE AND VIBRATORY SOUNDS. THE COMPLAINT OF A BLANK SCREEN WAS NOT DUPLICATED DURING INVESTIGATION. A LEAK TEST WAS PERFORMED AND A LEAK WAS FOUND DUE TO A CRACK BETWEEN UPPER RIGHT CORNER OF THE DISPLAY LENS AND THE CASE SEAL. THE PUMP COVER WAS REMOVED AND INTERNAL MOISTURE WAS PRESENT INSIDE THE PUMP. 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.

    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.

    Description of Event or Problem · 1

    ON (B)(6) 2013, THE REPORTER CONTACTED ANIMAS, ALLEGING A DISPLAY (BLANK SCREEN W/MOISTURE) ISSUE. THE DISPLAY ON THE ANIMAS PUMP REPORTEDLY IS BLANK BUT STILL MAKES SOUNDS. THERE WAS NO TRAUMA ISSUE; HOWEVER, THERE WAS A MOISTURE ISSUE. THE CONTRAST WAS SET ACCORDINGLY BUT THE ISSUE IS NOT RESOLVED. 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
    263040 ONETOUCHPING GLUCOSEMGMTSYSTEM INSULIN INFUSION PUMP LZG ANIMAS CORPORATION

    Patients

    Seq Age Sex Outcome Treatment
    1 34 YR