BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ONE TOUCH PING GLUCOSE MANAGEMENT SYSTEM

    MDR report key: 2020535 · Received February 16, 2011

    Report

    Report Number
    2531779-2011-00509
    Event Type
    Malfunction
    Date Received
    February 16, 2011
    Report Date
    December 30, 2010
    Manufacturer
    ANIMAS CORP.
    Product Code
    LZG
    PMA / PMN Number
    K080639
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    UNKNOWN

    Narratives

    Additional Manufacturer Narrative · 1

    THE PUMP HAS NOT BEEN RETURNED TO ANIMAS FOR EVALUATION. IF THE DEVICE IS RETURNED, AN EVALUATION SHALL BE COMPLETED AND A SUPPLEMENTAL REPORT WILL BE FILED. NO CONCLUSIONS CAN BE DRAWN AT THIS TIME.

    Description of Event or Problem · 1

    ON (B)(6) 2010, THE PATIENT CONTACTED ANIMAS ALLEGING THAT THE PUMP WAS SELF-REBOOTING. THE PATIENT DENIED THAT THE PUMP'S INTERNAL THREADS WERE STRIPPED. SHE DENIED THAT THE BATTERY CAP WAS DAMAGED. SHE ALSO STATED THAT THE O-RING, METAL TABS, AND THREADS WERE ALL IN PLACE. THE PATIENT DENIED THAT THE YELLOW O-RING WAS VISIBLE AND THAT THERE WERE ANY CRACKS AROUND THE OPENING OF THE BATTERY COMPARTMENT. BASED ON THE INFORMATION PROVIDED, THIS COMPLAINT IS BEING REPORTED DUE TO THE ALLEGATION THAT THE PUMP WAS REBOOTING. THERE IS NO EVIDENCE, HOWEVER, THAT THE ALLEGED ISSUE CAUSED OR CONTRIBUTED TO A SERIOUS INJURY. THE REPORTER DID NOT REPORT ANY HARM OR INJURY BECAUSE OF THE ALLEGED ISSUE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ONE TOUCH PING GLUCOSE MANAGEMENT SYSTEM INSULIN INFUSION PUMP LZG ANIMAS CORP. ONE TOUCH PING NA

    Patients

    Seq Age Sex Outcome Treatment
    1