BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ONETOUCHPING GLUCOSEMGMTSYSTEM

    MDR report key: 3903898 · Received June 30, 2014

    Report

    Report Number
    2531779-2014-18713
    Event Type
    Malfunction
    Date Received
    June 30, 2014
    Report Date
    June 26, 2014
    Manufacturer
    ANIMAS CORPORATION
    Product Code
    LZG
    PMA / PMN Number
    K080639
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    PATIENT

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE EVALUATION: THE PUMP HAS BEEN RETURNED AND EVALUATED BY PRODUCT ANALYSIS ON 09/08/2014 WITH THE FOLLOWING FINDINGS: A REVIEW OF THE PUMP BLACK BOX DATA REVEALED NO ERRORS, ALARMS, OR WARNINGS RELATED TO THE COMPLAINT. THE BASAL AND BOLUS DELIVERIES RECORDED ACCURATELY ADDED UP TO THE TOTAL DAILY DOSES. A DELIVERY ACCURACY TEST WAS PERFORMED AND SUCCESSFULLY PASSED. UNRELATED TO THE COMPLAINT, THE PUMP WAS POWERED ON AND THE DISPLAY SCREEN APPEARED DISCOLORED.

    Additional Manufacturer Narrative · 1

    THE PUMP 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 MADE AT THIS TIME.

    Description of Event or Problem · 1

    ON (B)(6) 2014, THE REPORTER CONTACTED ANIMAS, ALLEGING A HISTORY/SETTINGS (HISTORY/SETTINGS ISSUE) ISSUE. THE REPORTER STATED THAT THE PUMP DID NOT CALCULATE BOLUS TOTALS CORRECTLY. IT WAS REPORTED THAT THE USER BLOOD GLUCOSE (BG) READING WAS GREATER THAN 250 MG/DL; HOWEVER, THE BG READING DID NOT EXCEED 500 MG/DL. NO SYMPTOMS OF HYPERGLYCEMIA WERE REPORTED. THE ALLEGED BG EXCURSION DOES NOT MEET ANIMAS CRITERIA FOR A SERIOUS INJURY AND IS THEREFORE NOT REPORTABLE AS AN ADVERSE EVENT. THIS COMPLAINT IS BEING REPORTED BECAUSE THE REPORTED ISSUE WAS NOT RESOLVED WITH TROUBLESHOOTING. THERE WAS NO INDICATION THAT THE PRODUCT CAUSED OR CONTRIBUTED TO AN ADVERSE EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    381126 ONETOUCHPING GLUCOSEMGMTSYSTEM INSULIN INFUSION PUMP LZG ANIMAS CORPORATION

    Patients

    Seq Age Sex Outcome Treatment
    1 59 YR