BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ONETOUCHPING GLUCOSEMGMTSYSTEM

    MDR report key: 3002770 · Received March 13, 2013

    Report

    Report Number
    2531779-2013-02685
    Event Type
    Injury
    Date Received
    March 13, 2013
    Date of Event
    January 16, 2013
    Report Date
    February 18, 2013
    Manufacturer
    ANIMAS CORPORATION
    Product Code
    LZG
    PMA / PMN Number
    K080639
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AL, US
    Reporter Occupation
    OTHER

    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. 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

    DEVICE EVALUATION (B)(4) 2013: THE DEVICE WAS RETURNED TO ANIMAS AND EVALUATED BY PRODUCT ANALYSIS ON (B)(4) 2013 WITH THE FOLLOWING RESULTS: BLACK BOX REVIEW SHOWED A CANCELED BOLUS DUE 164 "EXCEEDS_REMAINING_INSULIN" WARNING, INSULIN LEVEL WAS 8U, AND A 10U BOLUS WAS ATTEMPTED. NO OTHER CANCELED BOLUSES WERE OBSERVED. THE TDD APPEARS TO BE ACCURATE AND TO ADD UP CORRECTLY . FORCE SENSOR CALIBRATION READING IS ABOVE NORMAL SPECIFICATION. .THE PUMP PASSES A 29 HOUR FLOW ACCURACY TEST AND FOUND TO BE DELIVERING WITHIN SPECIFICATION. .KEYPAD IS UNDAMAGED, ALL BUTTONS RESPOND APPROPRIATELY TO PRESSES. OPENED THE PUMP, THE POWER FLEX & THE FORCE SENSOR WERE TESTED FOR INTERMITTING CONDITIONS OR DAMAGE, NO DEFECTS WERE FOUND, NO MOISTURE INGRESS OBSERVED INSIDE .FORCE SENSOR RESISTANCE READING IS WITHIN SPEC AT 7.6K OHMS. UNRELATED TO THIS COMPLAINT, PUMP POWERS UP AND DISPLAYS "VERIFY" SCREEN, BUT THE DISPLAY WAS REDDISH AND FADED, A TEST DISPLAY WAS USED DURING INVESTIGATION AND IT WAS FULLY ILLUMINATED.

    Description of Event or Problem · 1

    ON (B)(6) 2013, THE REPORTER CONTACTED ANIMAS AND ALLEGED THE PATIENT WAS ADMITTED TO HOSPITAL ON (B)(6) 2013, WITH A DIAGNOSIS OF DIABETIC KETOACIDOSIS (DKA) AND A BLOOD GLUCOSE (BG) OF 680 MG/DL WITH SYMPTOMS. PATIENT'S HEALTH CARE PROVIDER (HCP) REVIEWED PUMP REPORT FROM DIASEND AND SAW THAT THERE WERE INCOMPLETE BOLUSES. PATIENT'S MOTHER STATES THAT THERE HAVE BEEN A COUPLE TIMES IN THE REPORTS WHERE IT SHOWS THAT THERE HAVE BEEN INCOMPLETE BOLUSES, BUT STATES THAT PUMP DOES NOT SHOW INCOMPLETE WHEN DELIVERING INSULIN. CUSTOMER TECHNICAL SUPPORT (CTS) REVIEWED PUMP WITH MOTHER, WHO STATES THAT PATIENT'S HCP WANTS PUMP REPLACED DUE TO INACCURATE DELIVERIES OF INSULIN. CTS REVIEW OF PUMP FOUND NO ANY INDICATIONS OF INACCURATE INSULIN DELIVERY OR HALT IN DELIVERY. REVIEWED BOLUS HISTORY, DOES NOT SHOW ANY INDICATIONS OF INCOMPLETE BOLUS DELIVERY. REVIEWED SUSPEND HISTORY, DOES NOT SHOW ANY LONG SUSPENDS IN HISTORY. CTS EDUCATED PATIENT'S MOTHER ON BACK UP INSULIN METHOD IF NEEDED AND TO CONTACT ANIMAS IF PATIENT CONTINUES TO HAVE ISSUES WITH PUMPS IN THE FUTURE. THIS COMPLAINT IS BEING REPORTED DUE TO THE ALLEGATION THAT A PATIENT DEVELOPED DKA RELATED TO ALLEGED INACCURATE DELIVERIES OF INSULIN BY THE PUMP.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    105651 ONETOUCHPING GLUCOSEMGMTSYSTEM INSULIN INFUSION PUMP LZG ANIMAS CORPORATION

    Patients

    Seq Age Sex Outcome Treatment
    1 11 YR Hospitalization