BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ONETOUCHPING GLUCOSEMGMTSYSTEM

    MDR report key: 3001602 · Received March 13, 2013

    Report

    Report Number
    2531779-2013-02644
    Event Type
    Injury
    Date Received
    March 13, 2013
    Report Date
    February 15, 2013
    Manufacturer
    ANIMAS CORPORATION
    Product Code
    LZG
    PMA / PMN Number
    K080639
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NV, US
    Reporter Occupation
    OTHER

    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. NO CONCLUSIONS CAN BE MADE AT THIS TIME.

    Additional Manufacturer Narrative · 1

    DEVICE EVALUATION FOLLOW-UP #1 SUBMITTED (B)(4) 2013: THE DEVICE WAS RETURNED TO ANIMAS AND EVALUATED BY PRODUCT ANALYSIS ON (B)(4) 2013 WITH THE FOLLOWING RESULTS: A 29 HOUR FLOW ACCURACY TEST WAS PERFORMED; PUMP PASSED FLOW ACCURACY TEST AND WAS FOUND TO BE DELIVERING WITHIN THE REQUIRED SPECIFICATIONS. A TIMEKEEPING ACCURACY TEST WAS PERFORMED; THE PUMP WAS KEEPING TIME ACCURATELY. PUMP EXERCISED FOR 24 HOURS. THE BATTERY WAS REMOVED. PUMP LEFT WITHOUT POWER FOR 6 HOURS; WHEN PUMP POWERED ON IT HAD RETURNED TO DEFAULT TIME AND DATE. PUMP OPENED AND THE INTERNAL BATTERY FOUND TO BE LEAKING. BLACK BOX SHOW MANUAL TIME CHANGE ON (B)(4) 2013 FROM 12:46AM TO 12:45PM. NO OTHER ACTIVITY OBSERVED IN PUMP HISTORIES RELATED TO THE COMPLAINT. DAILY INSULIN DELIVERY TOTALS APPEAR INCONSISTENT DUE TO TIME AND DATE CHANGE.

    Description of Event or Problem · 1

    THE PATIENT CONTACTED ANIMAS ON (B)(6) 2013, REPORTING THAT THEIR BLOOD GLUCOSE (BG) WAS 550MG/DL LAST NIGHT AND 500MG/DL AT 5AM THIS MORNING WITH INCREASED THIRST AND FREQUENT URINATION. THE PATIENT BOLUSED 8 UNITS AT 5:33AM AND 1.05UNITS AND 5:26AM. THE READING OF THE TIME ON THE PUMP WAS 5:33PM AND 5:26PM INSTEAD OF AM. THE BG RESPONDED TO CORRECTION BOLUS AND ONE HOUR LATER HIS BG WAS 300MG/DL AND TWO HOURS LATER HIS BG WAS 200MG/DL AND ONE HOUR AFTER THAT IT WAS 97MG/DL. THE REPORTED BG WAS NOT INDICATIVE OF A SERIOUS INJURY AND DOES NOT MEET THE ANIMAS CRITERIA OF AN ADVERSE EVENT. WHILE ON THE CALL THE PATIENT FELT NAUSEATED AND NOT FEELING WELL SO HE TREATED HIMSELF WITH MILK AND HIS BG CAME UP TO 168MG/DL. THE PATIENT FELT BETTER AND WAS READY TO PROCEED WITH REVIEWING THE PUMP. AT THE END OF THE CALL THE PATIENT'S BG WAS 79MG/DL. TROUBLESHOOTING INDICATED THAT THE TIME AND DATE WERE SET INCORRECTLY IN THE PUMP. THE PUMP WAS OFF BY ONE DAY AND WAS READING AM INSTEAD OF PM. THE PATIENT WAS NOT RECEIVING THE CORRECT AMOUNT OF INSULIN FOR THE TIME OF DAY DUE TO PUMP BEING INCORRECTLY PROGRAMMED. ALL BOLUSES WERE CONFIRMED AS BEING DELIVERED THROUGH THE PUMP AND NOT METER REMOTE. THE PATIENT STATED THAT HE DID NOT CHANGE THE TIME AND DATE AND DID NOT ADMIT TO POSSIBLE USER PROGRAMMING ERROR OR BEHAVIOR THAT CAUSED THE TIME AND DATE TO CHANGE. CUSTOMER SUPPORT (CS) ASKED THE PATIENT TO REBOOT THE PUMP AND THE PATIENT CONFIRMED THAT THE TIME AND DATE SAVED ON VERIFY SCREEN. THE TIME AND DATE IS NOT RESETTING. THE PATIENT CONFIRMED THE VERIFY SCREEN, COMPLETED REWIND AND LOAD AND PRIME SEQUENCE. THE PATIENT VERIFIED SEEING TIME IS READING AM INSTEAD OF PM. THE PUMP IS READING (B)(6) 2013. CS INSTRUCTED THE PATIENT THAT THEY WERE UNABLE TO IDENTIFY CAUSE OF THE TIME/DATE BEING INCORRECT AND THE PATIENT DENIED ANY POSSIBILITY OF USER ERROR/PROGRAMMING ERROR. CS INSTRUCTED PATIENT THAT THERE WAS NOTHING TO INDICATE THE PUMP WAS MALFUNCTIONING AND THAT THE MOST LIKELY CAUSE OF HIS ERRATIC BG IS DUE TO RECEIVING THE INCORRECT AMOUNT OF INSULIN AT THE INCORRECT TIME OF DAY - DUE TO TIME BEING OFF BY 12 HOURS. CS INSTRUCTED PATIENT TO DISCONTINUE PUMP AND IMPLEMENT AN ALTERNATE FORM OF INSULIN DELIVERY. INSTRUCTED PT TO CALL HIS DOCTOR AND GET ADVICE FOR DOSING HIMSELF. THIS REPORT IS BEING MADE DUE TO THE ALLEGED HYPERGLYCEMIA EVENT THE PATIENT EXPERIENCED DUE TO THE ALLEGED TIME AND DATE ISSUE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    105361 ONETOUCHPING GLUCOSEMGMTSYSTEM INSULIN INFUSION PUMP LZG ANIMAS CORPORATION

    Patients

    Seq Age Sex Outcome Treatment
    1 61 YR Life Threatening