BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ONETOUCHPING GLUCOSEMGMTSYSTEM

    MDR report key: 2110973 · Received June 2, 2011

    Report

    Report Number
    2531779-2011-03867
    Event Type
    Injury
    Date Received
    June 2, 2011
    Date of Event
    May 6, 2011
    Report Date
    May 7, 2011
    Manufacturer
    ANIMAS CORPORATION
    Product Code
    LZG
    PMA / PMN Number
    K080639
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    ANIMAS HAS CONDUCTED A REVIEW OF THE DEVICE HISTORY RECORD FOR THIS PUMP ON (B)(6) 2011 AND CONFIRMED THAT IT WAS OPERATING WITHIN REQUIRED SPECIFICATIONS AT THE TIME OF RELEASE. 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 FOR EVALUATION. IF THE DEVICE IS RETURNED, AN EVALUATION SHALL BE COMPLETED AND A SUPPLEMENTAL REPORT WILL BE FILED. NO CONCLUSION CAN BE MADE AT THIS TIME.

    Description of Event or Problem · 1

    THE PATIENT REPORTED THAT ON (B)(6) 2011 SHE EXPERIENCED BLOOD GLUCOSE (BG) OF HIGH ON THE METER (OVER 600 MG/DL) WITH NAUSEA. THE PATIENT WAS REPORTEDLY TAKEN TO THE ER AND ADMITTED TO THE HOSPITAL WITH BG OF 1000 MG/DL AND WAS PLACED ON INTRAVENOUS INSULIN. THE PATIENT'S BG WAS REPORTEDLY RESOLVED. CUSTOMER SUPPORT REVIEWED THE PUMP WITH THE PATIENT. THE PATIENT NOTED THAT THE PUMP WAS RUNNING A TEMP BASAL RATE OF ZERO UNITS PER HOUR FOR ABOUT ONE HOUR. THE PATIENT CONFIRMED THAT THE PRIME AND BOLUS HISTORIES ARE CORRECT; TOTAL DAILY DOSES ADD UP CORRECTLY. THE PATIENT CONFIRMED NO AIR BUBBLES OR BLOOD IN TUBING, AND NO LEAKING AT THE SITE. THIS REPORT IS MADE BECAUSE THE PATIENT EXPERIENCED HYPERGLYCEMIA WHILE USING 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 26 YR