BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ONETOUCHPING GLUCOSEMGMTSYSTEM

    MDR report key: 2933806 · Received January 29, 2013

    Report

    Report Number
    2531779-2013-01322
    Event Type
    Malfunction
    Date Received
    January 29, 2013
    Report Date
    January 23, 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

    THE PUMP HAS NOT BEEN RETURNED TO ANIMAS. 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. 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 03/29/2013 - DEVICE EVALUATION: THE PUMP HAS BEEN RETURNED AND EVALUATED BY PRODUCT ANALYSIS ON (B)(4) 2013 WITH THE FOLLOWING FINDINGS: DURING INVESTIGATION, THE PUMP HISTORY AND BLACK BOX DOWNLOADS WERE NOT AVAILABLE FOR REVIEW DUE TO MOISTURE IN THE PUMP. THERE WAS VISIBLE MOISTURE OBSERVED UNDER THE DISPLAY LENS. THE KEYPAD WAS FOUND TO BE PEELING UP NEAR THE OK KEY. DURING TESTING, THE PUMP DID NOT POWER ON AND NO AUDIBLE OR VIBRATORY SOUNDS WERE DETECTED. THE PUMP FAILED THE LEAK TEST DUE TO THE LEAK IN THE KEYPAD. THE PUMP WAS OPENED AND MOISTURE CORROSION WAS OBSERVED IN THE PUMP.

    Description of Event or Problem · 1

    THE REPORTER CONTACTED ANIMAS ON (B)(6) 2013, REPORTING THAT THE PATIENT'S PUMP WOULD NOT POWER ON. THE REPORTER INDICATED THAT THE PATIENT GOT OUT OF A POOL, FELT THE PUMP VIBRATE AND THE SCREEN WENT BLANK. THE REPORTER INDICATED THAT A NEW BATTERY WAS INSERTED BUT THE PUMP DID NOT TURN ON. THE REPORTER INDICATED THAT MOISTURE WAS OBSERVED BEHIND THE DISPLAY SCREEN. THE REPORTER CONFIRMED THAT THERE WAS NO KNOWN 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
    38625 ONETOUCHPING GLUCOSEMGMTSYSTEM INSULIN INFUSION PUMP LZG ANIMAS CORPORATION ONETOUCH PING INSULIN PUMP

    Patients

    Seq Age Sex Outcome Treatment
    1 18 YR