BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ONETOUCHPING GLUCOSEMGMTSYSTEM

    MDR report key: 3141281 · Received June 3, 2013

    Report

    Report Number
    2531779-2013-07471
    Event Type
    Injury
    Date Received
    June 3, 2013
    Report Date
    May 7, 2013
    Manufacturer
    ANIMAS CORPORATION
    Product Code
    LZG
    PMA / PMN Number
    K080639
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NV, US
    Reporter Occupation
    PATIENT

    Narratives

    Additional Manufacturer Narrative · 1

    THE PUMP HAS NOT BEEN RETURNED TO ANIMAS. ANIMAS HAS CONDUCTED A REVIEW OF THE DEVICE HISTORY RECORD FOR THIS PUMP AND CONFIRMED THAT IT WAS OPERATING WITHIN REQUIRED SPECIFICATIONS AT THE TIME OF RELEASE. 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 ALLEGING LOW BLOOD GLUCOSE (BG), USUALLY AT NIGHT, AT TIMES NOTICED AFTER SITE/SET CHANGE AND OTHER TIMES NOT ASSOCIATED WITH SITE/SET CHANGE. THE PATIENT STATED THAT HE DOES NOT CONTROL HIS BG WELL. THE PATIENT STATED HE WAS UNCERTAIN IF THE LOW BG WAS AFTER A BOLUS AND IF IT IS A BOLUS FOR HIGH BG OR DURING A MEAL. THE PATIENT STATED THAT HE USES THE PUMP FEATURES, BUT WAS NOT SURE IF THE LOW BG WAS OCCURRING AFTER GIVING BOLUSES FOR EZ-BG OR EZ-CARB. THE PATIENT STATED THAT HIS PREVIOUS HEALTHCARE PROVIDER HAD CHANGED HIS PUMP SETTINGS BUT WAS NOT CERTAIN WHAT WAS CHANGED, BUT STATED IT MIGHT HAVE BEEN THE BASAL RATE. THE PATIENT CONFIRMED THAT HIS CURRENT PUMP PROGRAMMING WAS ACCURATE. THE PATIENT STATED THAT HIS BG CAN GO AS LOW AS 40 MG/DL WITH CONFUSION, SWEATING AND TIREDNESS. THE PATIENT STATED THAT WHEN TREATING FOR LOW BG, HE SOMETIMES OVER-TREATS AND HIS BG WILL GO TOO HIGH AS A RESULT. THE PATIENT STATED THIS HAPPENED THIS WEEK AND HIS BG ELEVATED TO 500 MG/DL. THE PATIENT STATED HE TREATED THE HIGH BG WITH A BOLUS AND THE BG RESOLVED TO 180 MG/DL. REVIEW OF THE PUMP BY ANIMAS CUSTOMER TECHNICAL SUPPORT (ACTS) DID NOT REVEALED ANYTHING SIGNIFICANT IN THE HISTORY EXCEPT MULTIPLE SMALL PRIME VOLUMES. THE PATIENT CONFIRMED THAT HE DOES NOT COMPLETE THE CANNULA FILL STEP WHILE ATTACHED. ACTS EXPLAINED THE CANNULA IS TO BE DONE WHEN CONNECTED AND NEEDS TO FILL CANNULA. THE PATIENT WAS ADVISED TO FOLLOW UP WITH DIABETES EDUCATOR AND HCP. THIS COMPLAINT IS BEING REPORTED BECAUSE THE PATIENT EXPERIENCED BG EXCURSIONS WHILE ON INSULIN PUMP THERAPY RELATED TO IMPROPER USE AND PREVIOUS SETTINGS CHANGES PER HCP.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    244075 ONETOUCHPING GLUCOSEMGMTSYSTEM INSULIN INFUSION PUMP LZG ANIMAS CORPORATION

    Patients

    Seq Age Sex Outcome Treatment
    1 61 YR