BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ONETOUCHPING GLUCOSEMGMTSYSTEM

    MDR report key: 3181486 · Received June 21, 2013

    Report

    Report Number
    2531779-2013-08711
    Event Type
    Malfunction
    Date Received
    June 21, 2013
    Report Date
    May 25, 2013
    Manufacturer
    ANIMAS CORPORATION
    Product Code
    LZG
    PMA / PMN Number
    K080639
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OK, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE PUMP HAS NOT BEEN RETURNED TO ANIMAS. 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 08/22/2013 -DEVICE EVALUATION: THE PUMP HAS BEEN RETURNED AND EVALUATED BY PRODUCT ANALYSIS ON (B)(4) 2013 WITH THE FOLLOWING FINDINGS: DURING A VISUAL INSPECTION OF THE PUMP, A CRACK WAS FOUND ON THE DISPLAY LENS. THERE WAS MOISTURE VISIBLE BEHIND THE DISPLAY LENS. THE PUMP FAILED A LEAK TEST DUE TO A CRACK IN THE PUMP¿S CASING. THE PUMP COVER WAS OPENED AND MOISTURE WAS FOUND THROUGHOUT THE PUMP CASE. 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 A DISPLAY (DAMAGED W/ MOISTURE) ISSUE. THE REPORTER STATED THAT AFTER BEING EXPOSED TO WATER, THE DISPLAY SCREEN WAS BLANK AND THE LENS HAD EVIDENCE OF MOISTURE BEHIND IT. THE REPORTER NOTED A SMALL NICK IN THE LENS. 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
    283545 ONETOUCHPING GLUCOSEMGMTSYSTEM INSULIN INFUSION PUMP LZG ANIMAS CORPORATION

    Patients

    Seq Age Sex Outcome Treatment
    1 56 YR