BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ONETOUCHPING GLUCOSEMGMTSYSTEM

    MDR report key: 3240745 · Received July 22, 2013

    Report

    Report Number
    2531779-2013-11581
    Event Type
    Injury
    Date Received
    July 22, 2013
    Report Date
    June 23, 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

    FOLLOW-UP #1: DATE OF SUBMISSION 10/28/2013: DEVICE EVALUATION: THE DEVICE HAS BEEN RETURNED AND EVALUATED BY PRODUCT ANALYSIS ON 10/17/2013 WITH THE FOLLOWING FINDINGS: PUMP SUCCESSFULLY PASSED A 29-HR FLOW ACCURACY TEST. PUMP FOUND TO BE OPERATING WITHIN REQUIRED SPECIFICATIONS AND DELIVERING ACCURATELY. NO ALARMS OCCURRED DURING TESTING. THE LAST BASAL DELIVERY AND THE LAST BOLUS WERE RECORDED ON 06/23/2013. PUMP HISTORY SHOWS NO ALARMS OUTSIDE THE RANGE OF NORMAL PATIENT USE; NO ACTIVITY ASSOCIATED TO THE COMPLAINT WAS OBSERVED. THE BASAL AND BOLUSES ADD UP APPROPRIATELY TO TOTAL THE TDD; SHOWING THE PUMP WAS DELIVERING ACCURATELY. UNRELATED TO THE COMPLAINT, THE DISPLAY SCREEN HAS A PINKISH CONTRAST. REMOVED COVER AND REPLACED PINK DISPLAY WITH TEST DISPLAY. THE TEST SCREEN IS FULLY ILLUMINATED WITH NO VISIBLE SIGNS OF DISCOLORATION. 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 FOR EVALUATION. 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 LAY USER/PATIENT CONTACTED ANIMAS TO REPORT SHE HAS HAD AN ELEVATED BLOOD GLUCOSE (BG) FOR PAST DAY AND A HALF AND CLAIMED SHE TESTED POSITIVE FOR MODERATE KETONES. THE PATIENT STATED SHE WOKE UP WITH BG OF 257 MG/DL AND CORRECTED USING HER PUMP. THE PATIENT STATED SHE ATE AN APPLE AND THE AFTERNOON OF (B)(6) 2013 HER BG WAS UP TO 376 MG/DL. THE PATIENT CLAIMED SHE CORRECTED FOR THE ELEVATED BG USING THE PUMP. AT THE TIME OF THE CALL, THE PATIENT MENTIONED SHE HAD CHANGED HER SITE 3 TIMES SINCE HIGH BG STARTED ON MORNING OF (B)(6) 2013 AND HAD PROGRAMMED A TEMP BASAL RATE OF 40% FOR 16 HOURS; HOWEVER, HER BG CONTINUED TO BE ELEVATED WITH SIGNS OF MODERATE KETONES. THE PATIENT MENTIONED SHE STARTED GIVING HERSELF INJECTIONS WITH SYRINGE AND CLAIMED HER BG RESPONDED TO THE INJECTIONS. AT THE TIME OF TROUBLESHOOTING, THE PATIENT STATED SHE DISCONTINUED THE PUMP DUE TO ¿LOSING FAITH IN PRODUCT¿ AND CONFIRMED SHE WAS AN ALTERNATE METHOD OF INSULIN DELIVERY. THE PUMP SETTINGS AND HISTORY WERE REVIEWED. CUSTOMER TECHNICAL SUPPORT (CTS) NOTED THERE WERE NO ASSOCIATED ALARMS. THE PATIENT CONFIRMED DATE AND TIME WERE CORRECT, BASAL SEGMENTS AND ADVANCED FEATURES WERE PROGRAMMED AS INTENDED. IT WAS NOTED THAT BOLUS AND BASAL HISTORIES ALL ADDED UP IN TDD (TOTAL DAILY DELIVERY). THE PATIENT DENIED ANY BENT CANNULA¿S OR SITE ISSUES WITH SITE CHANGES. IN ADDITION, THE PATIENT CONFIRMED SHE WAS USING A NEW VIAL OF INSULIN AND DENIED CHANGES IN DIET, ACTIVITY, FEELING ILL OR TAKING ANY NEW MEDICATION(S). THIS COMPLAINT IS BEING REPORTED BECAUSE THE PATIENT DEVELOPED SIGNS/SYMPTOMS SUGGESTIVE OF A SERIOUS INJURY WHILE ON INSULIN PUMP THERAPY. ALTHOUGH REVIEW OF THE PUMP DID NOT CONFIRM A MALFUNCTION OF THE DEVICE, INSULIN PUMP USE COULD NOT BE RULED OUT AS A CAUSE OR CONTRIBUTOR TO THE EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    340214 ONETOUCHPING GLUCOSEMGMTSYSTEM INSULIN INFUSION PUMP LZG ANIMAS CORPORATION

    Patients

    Seq Age Sex Outcome Treatment
    1 24 YR Life Threatening| R