BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ONETOUCHPING GLUCOSEMGMTSYSTEM

    MDR report key: 2070214 · Received April 27, 2011

    Report

    Report Number
    2531779-2011-02913
    Event Type
    Injury
    Date Received
    April 27, 2011
    Date of Event
    March 29, 2011
    Report Date
    March 29, 2011
    Manufacturer
    ANIMAS CORPORATION
    Product Code
    LZG
    PMA / PMN Number
    K080639
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NJ, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE PUMP HAS NOT BEEN RETURNED TO ANIMAS FOR EVALUATION. 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. THE PATIENT HAS CONTINUED TO USE THE PUMP WITH NO REPORTED SUBSEQUENT EVENTS. 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. 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.

    Description of Event or Problem · 1

    A PHYSICIAN STATED THAT THE PATIENT ARRIVED AT THE EMERGENCY ROOM WITH BLOOD GLUCOSE (BG) OF 510MG/DL; HE DENIED A DIAGNOSIS OF DIABETIC KETOACIDOSIS. HE SAID THAT THE PATIENT WAS RELEASED FROM THE EMERGENCY ROOM WITH BG OF 360MG/DL. THE PATIENT CONTACTED CUSTOMER SUPPORT THE NEXT DAY AND STATED THAT HIS BG WAS STILL ELEVATED (300MG/DL). HE STATED THAT HE HAD NOT CHANGED THE INFUSION SET FOR THREE DAYS WHEN HE WAS HOSPITALIZED. THE PATIENT REPORTED THAT AFTER HE CHANGED THE INFUSION SET HIS BG RESOLVED TO 79MG/DL. THE PATIENT STATED THAT HE HAS USED INSULIN PUMP THERAPY FOR 15 YEARS AND HAS DEVELOPED SIGNIFICANT SCAR TISSUE. CUSTOMER SUPPORT ADVISED THE PATIENT TO DISCUSS INFUSION SITE SELECTION WITH HIS PHYSICIAN. THIS COMPLAINT IS BEING REPORTED BECAUSE THE HYPERGLYCEMIA WAS THE RESULT OF INSULIN PUMP THERAPY.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 56 YR Hospitalization| R