BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ONETOUCHPING GLUCOSEMGMTSYSTEM

    MDR report key: 2944580 · Received February 5, 2013

    Report

    Report Number
    2531779-2013-01490
    Event Type
    Injury
    Date Received
    February 5, 2013
    Date of Event
    December 25, 2012
    Report Date
    January 8, 2013
    Manufacturer
    ANIMAS CORPORATION
    Product Code
    LZG
    PMA / PMN Number
    K080639
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AR, US
    Reporter Occupation
    PATIENT

    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. IF THE DEVICE IS RETURNED, AN EVALUATION SHALL BE COMPLETED AND A SUPPLEMENTAL REPORT WILL BE FILED. THE REASON FOR THE ADVERSE EVENT HAS BEEN ATTRIBUTED TO USE ERROR (PATIENT'S LACK OF KNOWLEDGE ON THE FUNCTIONALITY OF THE PUMP).

    Description of Event or Problem · 1

    THE PATIENT CONTACTED ANIMAS ON (B)(6) 2013 REPORTING THAT SHE WAS ADMITTED TO THE HOSPITAL ON (B)(6)2012 WITH BLOOD GLUCOSE (BG) LEVELS IN THE 800'S MG/DL OR 900'S MG/DL. THE PATIENT REPORTED THAT SHE WAS NOT ON THE PUMP AT THE TIME OF THIS EVENT. THE PATIENT WAS ON INJECTIONS PER HER HEALTHCARE PROFESSIONAL. THIS MORNING HER BG WAS DOWN TO 364MG/DL. THE PATIENT STATED THAT SHE RESUMED THE PUMP ON (B)(6) 2012 AND THE PUMP IS CONTROLLING HER BG LEVEL. THE PATIENT STATED THAT SHE IS NOT SURE OF CARBOHYDRATE COUNTING AND HOW HIGH FAT FOODS AFFECTS BG. SHE STATED THAT SHE HAD SOME WEIGHT LOSS BUT NOT SURE HOW MUCH. CUSTOMER SUPPORT (CS) WALKED THE PATIENT THROUGH HOW TO USE THE EZCARB ON THE PUMP, WHEN TO USE THE CARBOHYDRATE SCREEN AND WHEN TO USE THE BG SCREEN. THE PATIENT CONTINUED TO MAKE ADJUSTMENTS IN THE BASAL RATE AND USING TEMPORARY BASAL IN BETWEEN. THE PATIENT STATED THE SHE TALKED TO HER HEALTHCARE PROFESSIONAL REGARDING PUMP INSTRUCTIONS. THE PUMP IS NOT BEING RETURNED. CUSTOMER SUPPORT ADVISED THE PATIENT THAT THERE WAS NO MALFUNCTION FOUND WITH THE PUMP. THIS REPORT IS BEING MADE DUE TO THE PATIENT'S ALLEGED HYPERGLYCEMIC EVENT THAT RESULTED FROM THE PATIENT'S LACK OF KNOWLEDGE ON THE FUNCTIONALITY OF THE PUMP.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    48151 ONETOUCHPING GLUCOSEMGMTSYSTEM INSULIN INFUSION PUMP LZG ANIMAS CORPORATION ONETOUCH PING INSULIN PUMP

    Patients

    Seq Age Sex Outcome Treatment
    1 43 YR Hospitalization