BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ONETOUCHPING GLUCOSEMGMTSYSTEM

    MDR report key: 2834015 · Received November 15, 2012

    Report

    Report Number
    2531779-2012-13658
    Event Type
    Malfunction
    Date Received
    November 15, 2012
    Report Date
    November 8, 2012
    Manufacturer
    ANIMAS CORPORATION
    Product Code
    LZG
    PMA / PMN Number
    K080639
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GA, 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

    (B)(4): THE PUMP DID NOT POWER ON FOR TESTING. VISIBLE MOISTURE WAS OBSERVED BEHIND THE DISPLAY LENS. MOISTURE DAMAGE WAS FOUND IN THE PUMP; A LEAK TEST WAS PERFORMED AND REVEALED A DISPLAY LENS LEAK. THE KEYPAD BUTTONS COULD NOT BE TESTED. THE KEYPAD WAS REMOVED AND NO KEYPAD DAMAGE WAS FOUND.

    Description of Event or Problem · 1

    THE REPORTER CONTACTED ANIMAS ON (B)(6) 2012, STATING THAT THE UP ARROW, DOWN ARROW AND OK KEYPAD BUTTONS WERE UNRESPONSIVE AFTER BEING EXPOSED TO WATER. THE REPORTER STATED THAT THERE WAS EVIDENCE OF MOISTURE BEHIND THE LCD SCREEN. THE PATIENT DENIED ANY EVIDENCE OF DAMAGE TO THE KEYPAD. THE PATIENT REPORTEDLY WORE THE PUMP IN A CASE ON A BELT AND DID NOT CLEAN THE PUMP. THERE IS NO ADVERSE EVENT WITH THIS COMPLAINT. THIS COMPLAINT IS BEING REPORTED DUE TO THE ALLEGED KEYPAD ISSUES.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 13 YR