BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ONETOUCHPING GLUCOSEMGMTSYSTEM

    MDR report key: 3120169 · Received May 20, 2013

    Report

    Report Number
    2531779-2013-06695
    Event Type
    Malfunction
    Date Received
    May 20, 2013
    Report Date
    April 23, 2013
    Manufacturer
    ANIMAS CORPORATION
    Product Code
    LZG
    PMA / PMN Number
    K080639
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, 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 PATIENT CONTACTED ANIMAS ON (B)(6) 2013 REPORTING THAT THE INSULIN ON BOARD FEATURE WAS INDICATING MORE INSULIN THAN WAS EXPECTED. THE PATIENT REPORTED THAT UPON CALCULATING A BOLUS FOR BREAKFAST IN THE MORNING, THE PUMP INDICATED 3.5 UNITS OF INSULIN ON BOARD BUT THE LAST BOLUS WAS AROUND 5 PM THE NIGHT BEFORE. THERE WAS NO INDICATION THAT THIS ISSUE MAY HAVE CAUSED OR CONTRIBUTED TO AN ADVERSE EVENT. THIS REPORT IS MADE BASED ON THE ALLEGATION THAT THE PUMP INSULIN ON BOARD CALCULATION WAS INCORRECT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    222599 ONETOUCHPING GLUCOSEMGMTSYSTEM INSULIN INFUSION PUMP LZG ANIMAS CORPORATION

    Patients

    Seq Age Sex Outcome Treatment
    1 68 YR