BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ONETOUCHPING GLUCOSEMGMTSYSTEM

    MDR report key: 3242509 · Received July 23, 2013

    Report

    Report Number
    2531779-2013-11698
    Event Type
    Injury
    Date Received
    July 23, 2013
    Report Date
    June 26, 2013
    Manufacturer
    ANIMAS CORPORATION
    Product Code
    LZG
    PMA / PMN Number
    K080639
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    PATIENT

    Narratives

    Additional Manufacturer Narrative · 1

    THE PUMP HAS NOT BEEN RETURNED TO ANIMAS. 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. NO CONCLUSIONS CAN BE MADE AT THIS TIME.

    Additional Manufacturer Narrative · 1

    THE DEVICE HAS BEEN RETURNED AND EVALUATED BY PRODUCT ANALYSIS ON 09/18/2013 WITH THE FOLLOWING FINDINGS: A REVIEW OF THE BLACK BOX SHOWS A ¿REPLACE CARTRIDGE¿ ALARM ON (B)(6) 2013 AT 01:31. THE ALARM WAS CONFIRMED AT 06:58; DELIVERIES WERE NOT RESUMED. NO ALARMS RELATED TO THE COMPLAINT WERE NOTED IN THE ALARM HISTORY; ONLY TYPICAL USAGE WAS OBSERVED. THE BASAL AND BOLUSES ADD UP PROPERLY TO TOTAL THE TOTAL DAILY DOSE; SHOWING THE PUMP WAS DELIVERING ACCURATELY UNTIL THE LAST DATE USED. THE PUMP SUCCESSFULLY COMPLETED A 29 HOUR FLOW ACCURACY TEST. NO ALARMS OCCURRED DURING TESTING. THE PUMP WAS FOUND TO BE OPERATING WITHIN REQUIRED SPECIFICATIONS AND DELIVERING ACCURATELY. A REPLACE CARTRIDGE ALARM WAS REPRODUCED FOR THE INVESTIGATION; THE PUMP GAVE THE APPROPRIATE VIBRATION AND DISPLAYED THE CORRECT MESSAGE ON THE SCREEN. NO DEFECT WAS FOUND ON INVESTIGATION.

    Description of Event or Problem · 1

    THE PATIENT CONTACTED ANIMAS ON (B)(4) 2013 REPORTING BLOOD GLUCOSE LEVELS UP TO 360 MG/DL WITH NAUSEA, THIRST, AND CONFUSION. THE PATIENT INDICATED THAT IT WAS NOT UNCOMMON FOR BLOOD GLUCOSE LEVELS TO BE ELEVATED TO HI ON THE METER (OVER 600 MG/DL). NO TROUBLESHOOTING OF THE PUMP WAS ABLE TO BE COMPLETED DUE TO AN UNRELATED DISPLAY ISSUE. THE PATIENT WAS ADVISED TO USE A BACK UP TREATMENT PLAN UNTIL THE PUMP CAN BE REPLACED. THIS REPORT IS MADE BASED ON THE ALLEGATION THAT THE PATIENT EXPERIENCED HYPERGLYCEMIA OF UNCLEAR CAUSE WHILE USING INSULIN PUMP THERAPY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    343027 ONETOUCHPING GLUCOSEMGMTSYSTEM INSULIN INFUSION PUMP LZG ANIMAS CORPORATION

    Patients

    Seq Age Sex Outcome Treatment
    1 59 YR Life Threatening