BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ONE TOUCH PING GLUCOSE MANAGEMENT SYSTEM

    MDR report key: 2070533 · Received March 29, 2011

    Report

    Report Number
    2531779-2011-02031
    Event Type
    Malfunction
    Date Received
    March 29, 2011
    Date of Event
    March 1, 2011
    Report Date
    March 1, 2011
    Manufacturer
    ANIMAS CORP.
    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

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

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PUMP RECORDED TWO 0.0 UNIT BOLUSES WHICH THE PT REPORTED HE DID NOT DELIVER. THE PT STATED THAT HE NOTICED THE TWO 0.0 UNIT BOLUSES BECAUSE HE HAS BG REMINDERS SET FOR TWO HOURS POST-BOLUS. HE REPORTED THAT HE WEARS THE PUMP ON HIS WAIST. THE PT CONFIRMED THAT THERE IS NO DAMAGE TO THE RUBBER KEYPAD. HE STATED THAT HE COULD NOT HAVE PRESSED ANY BUTTONS ACCIDENTLY BECAUSE HE KEEPS THE PUMP LOCKED.

    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

    Patients

    Seq Age Sex Outcome Treatment
    1 18 YR