BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ONETOUCHPING GLUCOSEMGMTSYSTEM

    MDR report key: 3193089 · Received June 27, 2013

    Report

    Report Number
    2531779-2013-09127
    Event Type
    Injury
    Date Received
    June 27, 2013
    Date of Event
    June 26, 2013
    Report Date
    May 28, 2013
    Manufacturer
    ANIMAS CORPORATION
    Product Code
    LZG
    PMA / PMN Number
    K080639
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    A REVIEW OF THE TOTAL DAILY DOSE HISTORY INDICATED THAT INSULIN DELIVERY TOTALS CORRECTLY REFLECTED PROGRAMMED VALUES. THE PUMP WAS EVALUATED AND FOUND TO BE OPERATING WITHIN REQUIRED SPECIFICATIONS AND DELIVERING INSULIN ACCURATELY. THE PUMP WAS EXERCISED FOR 29 HOURS WITH NO ISSUES. THIS REPORT IS MADE UNDER THE REQUIREMENTS OF THE MEDICAL DEVICE REPORTING REGULATIONS AND DOES NOT CONSTITUTE AN ADMISSION ON THE PART OF ANIMAS OF ANY DEFICIENCY IN THE PERFORMANCE OF THE DEVICE.

    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. 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.

    Description of Event or Problem · 1

    ON (B)(6) 2013, ANIMAS WAS INFORMED THAT THE PATIENT HAD BEEN EXPERIENCING HIGH BLOOD GLUCOSE (BG) WITH ER VISITS, CAUSING HIM TO GO OFF THE PUMP. DETAILS OF THE REPORTED INCIDENTS WERE NOT PROVIDED. THE PATIENT REPORTEDLY WAS OFF THE PUMP AND HAD BEEN ON INSULIN INJECTIONS FOR ¿THE PAST FEW WEEKS¿. THE PATIENT REPORTEDLY EXPERIENCED ELEVATED BG OVER 500MG/DL ON (B)(6) 2013. DETAILS OF TREATMENT FOR THAT BG EXCURSION WERE NOT PROVIDED. THE REPORTER MENTIONED MULTIPLE ALARMS BUT DID NOT SPECIFY IF THESE RESULTED IN BG EXCURSIONS OR NOT. THE PATIENT HAS REPORTEDLY REQUESTED ADDITIONAL INFUSION SET TRAINING SO THAT HE CAN RESUME THE PUMP. THERE WERE MULTIPLE INFUSION SET ISSUES NOTED, AND THOSE COMPLAINTS HAVE BEEN FORWARDED TO THE APPROPRIATE MANUFACTURER. THIS COMPLAINT IS BEING REPORTED BASED ON THE ALLEGATION THAT THE PATIENT EXPERIENCED HYPERGLYCEMIA OF UNKNOWN CAUSE BOTH WHILE USING THE PUMP AND WHILE ON A BACK-UP PLAN OF INSULIN INJECTIONS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    292804 ONETOUCHPING GLUCOSEMGMTSYSTEM INSULIN INFUSION PUMP LZG ANIMAS CORPORATION

    Patients

    Seq Age Sex Outcome Treatment
    1 44 YR Life Threatening| R