BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ONE TOUCH PING GLUCOSE MANAGEMENT SYSTEM

    MDR report key: 2063003 · Received April 11, 2011

    Report

    Report Number
    2531779-2011-02501
    Event Type
    Malfunction
    Date Received
    April 11, 2011
    Date of Event
    March 13, 2011
    Report Date
    March 13, 2011
    Manufacturer
    ANIMAS CORPORATION
    Product Code
    LZG
    PMA / PMN Number
    K080639
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NC, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

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

    Description of Event or Problem · 1

    THE REPORTER CLAIMED THE ANIMAS INSULIN PUMP WILL NOT TURN ON. THERE WAS NO REPORT OF SYMPTOMS OR MEDICAL INTERVENTION THAT WOULD SUGGEST A SERIOUS INJURY. DURING TROUBLESHOOTING, THE REPORTER INDICATED THAT SHE REPLACED THE BATTERY ON THE ANIMAS PRODUCT BUT THE ISSUE WAS NOT RESOLVED. THIS COMPLAINT IS BEING REPORTED AS A MALFUNCTION DUE TO THE POWER ISSUE. THERE WAS NO ADVERSE EVENT ASSOCIATED WITH THIS COMPLAINT.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 78 YR