BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ONETOUCHPING GLUCOSEMGMTSYSTEM

    MDR report key: 2973646 · Received February 22, 2013

    Report

    Report Number
    2531779-2013-02018
    Event Type
    Malfunction
    Date Received
    February 22, 2013
    Report Date
    January 24, 2013
    Manufacturer
    ANIMAS CORPORATION
    Product Code
    LZG
    PMA / PMN Number
    K080639
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    PATIENT

    Narratives

    Additional Manufacturer Narrative · 1

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

    Description of Event or Problem · 1

    THE REPORTER CONTACTED ANIMAS ON (B)(6) 2013 INDICATING THAT SEVERAL TIMES OVER THE LAST WEEK THE PUMP WILL ALARM THAT PART OF A BOLUS PROGRAMMED ON THE METER REMOTE WAS NOT DELIVERED. THE PATIENT INDICATED THAT THEY WATCH THE METER COUNT DOWN TO ZERO AS IF THE BOLUS WAS DELIVERED, BUT WITHIN 1 HOUR THE PUMP ALARMS. THE PATIENT REVIEWED THE PUMP HISTORY AND IT INDICATES THAT ONLY PART OF THE BOLUS WAS DELIVERED. THIS REPORT IS BEING MADE BASED ON THE INDICATION THAT THE PUMP IS SHOWING THAT THE BOLUS IS DELIVERED, BUT WILL LATER ALARM TO INDICATE THAT IT WAS NOT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    78669 ONETOUCHPING GLUCOSEMGMTSYSTEM INSULIN INFUSION PUMP LZG ANIMAS CORPORATION ONETOUCH PING INSULIN PUMP

    Patients

    Seq Age Sex Outcome Treatment
    1 43 YR