BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ONETOUCHPING GLUCOSEMGMTSYSTEM

    MDR report key: 3930067 · Received July 11, 2014

    Report

    Report Number
    2531779-2014-19779
    Event Type
    Injury
    Date Received
    July 11, 2014
    Date of Event
    July 1, 2014
    Report Date
    July 2, 2014
    Manufacturer
    ANIMAS CORPORATION
    Product Code
    LZG
    PMA / PMN Number
    K080639
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MS, US
    Reporter Occupation
    PATIENT

    Narratives

    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.

    Additional Manufacturer Narrative · 1

    THE DEVICE HAS BEEN RETURNED AND EVALUATED BY PRODUCT ANALYSIS ON 09/18/2014 WITH THE FOLLOWING FINDINGS: NO ACTIVITY RELATED TO THE INITIAL COMPLAINT WAS OBSERVED IN THE PUMP HISTORIES. DAILY INSULIN DELIVERY TOTALS CORRECTLY REFLECTED THE USER'S PROGRAMMED BASAL RATES. NO DAMAGE WAS FOUND TO THE CARTRIDGE CAP OR CARTRIDGE COMPARTMENT. THE CARTRIDGE CAP ATTACHED SECURELY TO THE PUMP. THE PUMP WAS FOUND TO REWIND FULLY DURING THE REWIND STEP AND DISPLAYED THE APPROPRIATE WARNING: ¿DISCONNECT INFUSION SET FROM YOUR BODY¿. THE PUMP PASSED A FLOW ACCURACY TEST AND WAS FOUND TO BE DELIVERING WITHIN THE REQUIRED SPECIFICATIONS. UNRELATED TO THE INITIAL COMPLAINT, THE DISPLAY WAS OBSERVED TO BE DIM WITH RED LETTERS. 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) 2014, THE REPORTER CONTACTED ANIMAS ALLEGING A HYPOGLYCEMIC EVENT. THE REPORTER STATED THAT ON (B)(6) 2014 THE PATIENT HAD BLOOD GLUCOSE OF 25 MG/DL WITH SLURRED SPEECH, WAS INCOHERENT, COMBATIVE, AND IN AND OUT OF CONSCIOUSNESS. REPORTEDLY, THE PATIENT WAS TREATED IN THE ER WITH IV GLUCOSE; THERE WERE NO PUMP SETTING CHANGES BEFORE OR AFTER THE ALLEGED EVENT AND PUMP USE RESUMED. IT WAS REPORTED THAT THE PATIENT EXPERIENCED AN INADVERTENT INFUSION DUE TO TIGHTENING THE CAP WHILE ATTACHED. THIS COMPLAINT IS BEING REPORTED FOR ALLEGED HYPOGLYCEMIA ASSOCIATED WITH USE ERROR OF THE PUMP.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    406073 ONETOUCHPING GLUCOSEMGMTSYSTEM INSULIN INFUSION PUMP LZG ANIMAS CORPORATION

    Patients

    Seq Age Sex Outcome Treatment
    1 75 YR Life Threatening| R