BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ONETOUCHPING GLUCOSEMGMTSYSTEM

    MDR report key: 2072210 · Received April 28, 2011

    Report

    Report Number
    2531779-2011-02971
    Event Type
    Malfunction
    Date Received
    April 28, 2011
    Date of Event
    April 2, 2011
    Report Date
    April 2, 2011
    Manufacturer
    ANIMAS CORPORATION
    Product Code
    LZG
    PMA / PMN Number
    K080639
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AZ, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    AFTER THE EVALUATION IS COMPLETED AND A SUPPLEMENTAL REPORT WILL BE FILED. NO CONCLUSIONS CAN BE DRAWN AT THIS TIME.

    Additional Manufacturer Narrative · 1

    FOLLOW-UP #1 12/20/2011-DEVICE EVALUATION: THE PUMP HAS BEEN RETURNED AND EVALUATED BY PRODUCT ANALYSIS ON (B)(6) 2011 WITH THE FOLLOWING FINDINGS: A REVIEW OF THE BLACK BOX SHOWED THAT REBOOTING HAD OCCURRED. NO PHYSICAL DAMAGE WAS NOTED TO THE PUMP. THE PUMP BOOTED TO THE VERIFY SCREEN WITH APPROPRIATE ALARMS. THE BATTERY CAP WAS TESTED; REBOOTING WAS DUPLICATED AND THE BATTERY CAP CONTACTS WERE FOUND TO BE OUT OF SPECIFICATION. A TEST BATTERY CAP WAS INSERTED TO CONTINUE TESTING. THE PUMP CURRENT DRAWS WERE TESTED AND FOUND TO BE WITHIN SPECIFICATIONS. THE PUMP WAS EXERCISED FOR 24 HOURS WITHOUT REBOOTING. THE PUMP WAS OPENED AND AN ELECTRICAL COMPONENT WAS FOUND TO HAVE BROKEN OFF THE PCB.

    Description of Event or Problem · 1

    THIS COMPLAINT IS BEING REPORTED DUE TO THE ALLEGED SELF-REBOOT ISSUES. THERE WAS NO REPORT OF PRODUCT MISUSE. THE REPORTER INDICATED THERE WAS NO CORROSION OR MOISTURE IN THE BATTERY COMPARTMENT, THE BATTERY CAP IS INTACT, THERE WAS NO STRUCTURAL DAMAGE, AND THERE WAS SEVERAL BATTERY ALARM MESSAGE SINCE THE ANIMAS PUMP WAS INITIALLY DROPPED. FURTHERMORE, THERE WAS NO ADVERSE EVENT ASSOCIATED WITH THIS COMPLAINT.

    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 14 YR