BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ONETOUCHPING GLUCOSEMGMTSYSTEM

    MDR report key: 3130415 · Received May 24, 2013

    Report

    Report Number
    2531779-2013-07060
    Event Type
    Malfunction
    Date Received
    May 24, 2013
    Report Date
    May 16, 2013
    Manufacturer
    ANIMAS CORPORATION
    Product Code
    LZG
    PMA / PMN Number
    K080639
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    FOLLOW-UP # 1 DATE OF SUBMISSION (B)(4) 2013-DEVICE EVALUATION: THE PUMP HAS BEEN RETURNED AND EVALUATED BY PRODUCT ANALYSIS ON (B)($) 2013 WITH THE FOLLOWING FINDINGS: DURING TESTING, THE PUMP WAS UNABLE TO POWER ON AND VISIBLE MOISTURE WAS BEHIND THE DISPLAY LENS. THE PUMP FAILED AN IN HOUSE LEAK TEST DUE TO A CRACK BETWEEN THE CASE SEAL AND THE UPPER RIGHT HAND CORNER OF THE DISPLAYS LENS. THE PUMP COVER WAS REMOVED AND THERE WAS EVIDENCE OF INTERNAL MOISTURE. 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. 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

    THE PATIENT CONTACTED ANIMAS ON (B)(6) 2013 REPORTING THAT THE PUMP STOPPED WORKING AFTER SWIMMING WITH THE PUMP. THE PATIENT INDICATED THAT THERE WERE BUBBLES BEHIND THE DISPLAY SCREEN BUT CONFIRMED THAT THERE WAS NO DAMAGE TO THE PUMP. THIS REPORT IS MADE BASED ON THE ALLEGATION OF THE PUMP POWER ISSUE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    231327 ONETOUCHPING GLUCOSEMGMTSYSTEM INSULIN INFUSION PUMP LZG ANIMAS CORPORATION

    Patients

    Seq Age Sex Outcome Treatment
    1 33 YR