BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ONETOUCHPING GLUCOSEMGMTSYSTEM

    MDR report key: 3050794 · Received April 10, 2013

    Report

    Report Number
    2531779-2013-04007
    Event Type
    Injury
    Date Received
    April 10, 2013
    Date of Event
    March 13, 2013
    Report Date
    March 15, 2013
    Manufacturer
    ANIMAS CORPORATION
    Product Code
    LZG
    PMA / PMN Number
    K080639
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NC, US
    Reporter Occupation
    PATIENT

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE EVALUATION: THE DEVICE HAS BEEN RETURNED AND EVALUATED BY PRODUCT ANALYSIS ON 11/01/2014 WITH THE FOLLOWING FINDINGS: THE BLACK BOX BEGAN ON (B)(6) 2014 DUE TO CONTINUOUS USE OF THE PUMP; THE DATA AND HISTORY FOR THE EVENT ON (B)(6) 2013 HAVE BEEN OVERWRITTEN. A REVIEW OF THE AVAILABLE PUMP HISTORY SHOWED NO ERRORS, ALARMS, OR WARNINGS RELATED TO THE COMPLAINT. THE TOTAL DAILY DOSES ADDED UP CORRECTLY AND REFLECTED THE USER¿S PROGRAMMED BASAL RATE. THE PUMP SUCCESSFULLY PASSED A DELIVERY ACCURACY TEST AND WAS FOUND TO BE OPERATING WITHIN REQUIRED RANGE. THE ORIGINAL COMPLAINT COULD NOT BE DUPLICATED. THE RETURNED BATTERY AND CARTRIDGE CAPS WERE USED TO COMPLETE THE INVESTIGATION. 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.

    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.

    Description of Event or Problem · 1

    ON (B)(6) 2013 THE REPORTER CONTACTED ANIMAS FOR ASSISTANCE IN ADJUSTING PUMP SETTINGS, AND DURING THE CALL MENTIONED THAT ON (B)(6) 2013 THE PATIENT EXPERIENCED ELEVATED BLOOD GLUCOSE (BG) OF 300MG/DL WITH STOMACHACHE AND NAUSEA. THE REPORTER NOTED THAT THE PATIENT EXPERIENCES SYMPTOMS ANY TIME HIS BG IS OUT OF TARGET. THE PATIENT'S BG REPORTEDLY RESOLVED AFTER TWO BOLUSES. THE PATIENT IS REPORTEDLY WORKING WITH A HEALTHCARE PROVIDER (HCP) FOR SETTINGS ADJUSTMENTS. THERE WAS NO ALLEGATION OF A PRODUCT MALFUNCTION AND THE PATIENT HAS REPORTEDLY REMAINED ON INSULIN PUMP THERAPY. THIS COMPLAINT IS BEING REPORTED BECAUSE THE PATIENT ALLEGEDLY EXPERIENCED HYPERGLYCEMIA WHILE ON INSULIN PUMP THERAPY AND IT IS UNCLEAR AT THIS TIME IF THE REPORTED INCIDENT CAN BE ATTRIBUTED SOLELY TO DIABETES MANAGEMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    149783 ONETOUCHPING GLUCOSEMGMTSYSTEM INSULIN INFUSION PUMP LZG ANIMAS CORPORATION

    Patients

    Seq Age Sex Outcome Treatment
    1 11 YR Life Threatening