BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ANIMAS INSULIN INFUSION PUMP

    MDR report key: 2050594 · Received March 15, 2011

    Report

    Report Number
    2531779-2011-01604
    Event Type
    Malfunction
    Date Received
    March 15, 2011
    Report Date
    February 14, 2011
    Manufacturer
    ANIMAS CORP.
    Product Code
    LZG
    PMA / PMN Number
    K080639
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AR, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE 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

    THE REPORTER REPORTED THE INSULIN PUMP LOSES DATE/TIME AND REVERTS TO JANUARY 2001 12:00 AM AFTER EVERY BATTERY CHANGE. THE PATIENT ALLEGED NO INJURY OR MEDICAL ATTENTION DUE TO THIS ISSUE. THE PATIENT WAS ABLE TO CORRECT THE PUMP DATE/TIME AFTER EVERY BATTERY REPLACEMENT.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1