BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ONETOUCHPING GLUCOSEMGMTSYSTEM

    MDR report key: 2072940 · Received April 29, 2011

    Report

    Report Number
    2531779-2011-02991
    Event Type
    Malfunction
    Date Received
    April 29, 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
    VA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    AFTER THE EVALUATION IS COMPLETED AND A SUPPLEMENTAL REPORT WILL BE FILLED. NO CONCLUSIONS CAN BE DRAWN AT THIS TIME. THE REPORT IS UNDER THE REQUIREMENTS OF THE MEDICAL DEVICE REPORTING REGULATIONS AND DOES NOT CONSTITUTE AN ADMISSION ON THE PART OF ANIMAS OF ANY DEFICIENCY IN THE PERFORMANCE OF THE DEVICE.(B)(4)

    Description of Event or Problem · 1

    THE REPORTER CLAIMED THAT THERE IS A SELF REBOOT ISSUE WITH THE ONETOUCH PING INSULIN PUMP. REPORTEDLY, THE PUMP RANDOMLY REBOOTS ITSELF ESPECIALLY WHEN ANYTHING BUMPS THE PUMP. THERE IS NO SERIOUS INJURY ASSOCIATED WITH THIS COMPLAINT. DURING TROUBLESHOOTING, THE ANIMAS HEALTHCARE REPRESENTATIVE NOTED THAT THERE WAS NO TRAUMA TO THE PUMP, BATTERY CAP IS LESS THAN SIX MONTHS OLD, AND SECURES WITHOUT DIFFICULTY. THIS COMPLAINT IS BEING REPORTED AS A MALFUNCTION DUE TO THE ALLEGED SELF-REBOOT ISSUE.

    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 29