BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ONETOUCHPING GLUCOSEMGMTSYSTEM

    MDR report key: 3060953 · Received April 16, 2013

    Report

    Report Number
    2531779-2013-04318
    Event Type
    Malfunction
    Date Received
    April 16, 2013
    Report Date
    March 20, 2013
    Manufacturer
    ANIMAS CORPORATION
    Product Code
    LZG
    PMA / PMN Number
    K080639
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE PUMP HAS BEEN RETURNED TO ANIMAS. EVALUATION HAS NOT YET BEEN COMPLETED. WHEN EVALUATION IS COMPLETE A SUPPLEMENTAL REPORT WILL BE FILED. NO CONCLUSION 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

    FOLLOW-UP # 1 (B)(4) DEVICE EVALUATION: THE PUMP HAS BEEN RETURNED AND EVALUATED BY PRODUCT ANALYSIS ON (B)(4) 2013 WITH THE FOLLOWING FINDINGS: DURING INVESTIGATION, THE PUMP¿S HISTORY WAS REVIEWED AND SHOWED NO ACTIVITY OUTSIDE OF NORMAL USE. NO DELIVERY INTERRUPTION WAS OBSERVED; THE LAST BASAL DELIVERY WAS RECORDED ON (B)(6) 2013. THE TOTAL DAILY DOSE OF INSULIN ADDED UP CORRECTLY AND MATCHED THE USER¿S PROGRAMMED BASAL RATE TARGET. THE BASAL HISTORY RECORDED A ZERO UNIT/HOUR PROGRAM ON (B)(6) 2013 AT 1:54PM WHICH COINCIDES WITH AN ¿EZ-PRIME¿ OPERATION IN THE HISTORY. A ZERO UNIT/HOUR PROGRAM WAS OBSERVED AT 10:44PM THE SAME DAY WHICH COINCIDES WITH A ¿165: EXCEEDS MAX TDD LIMIT¿ WARNING SHOWED IN THE HISTORY. THE PUMP WAS PRIMED AND EXERCISED FOR 24 HOURS ON 1 UNIT/HOUR BASAL PROGRAM WITH NO DELIVERY INTERRUPTION OCCURRING. PERIODIC BOLUSES WERE EXECUTED SUCCESSFULLY USING ¿NORMAL¿, ¿EZ-CARB¿, ¿EZ-BG¿, AND ¿COMBO¿ AND RECORDED ACCURATELY IN THE HISTORY. THE PUMP PASSED A 29 HOUR FLOW ACCURACY TEST. DURING TESTING, THE KEYPAD WAS FOUND TO BE INTACT AND ALL BUTTONS RESPOND APPROPRIATELY. UNRELATED TO THE COMPLAINT, EVALUATION REVEALED A DIM DISPLAY. A TEST SCREEN WAS INSERTED AND WAS FOUND TO FUNCTION PROPERLY. THE COVER WAS REMOVED AND NO MOISTURE WAS FOUND INSIDE THE PUMP. NO INTERMITTENT CONDITION WAS FOUND TO THE POWER CIRCUIT AND FORCE SENSOR CIRCUIT.

    Description of Event or Problem · 1

    ON (B)(6) 2013, THE REPORTER CONTACTED ANIMAS STATING HE HAS BEEN EXPERIENCING ELEVATED BLOOD GLUCOSE (BG) UP TO 250MG/DL AND WILL EXERCISE OR ADMINISTER A CORRECTION INJECTION. REVIEW OF THE PUMP HISTORY SHOWS 0 UNIT BASAL DELIVERY IN THE HISTORY WHICH COULD NOT BE EXPLAINED. THE REPORTED BG EXCURSION DOES NOT MEET CRITERIA FOR A SERIOUS INJURY. THIS COMPLAINT IS BEING REPORTED BECAUSE THE BASAL HISTORY ISSUE WAS NOT RESOLVED WITH TROUBLESHOOTING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    163692 ONETOUCHPING GLUCOSEMGMTSYSTEM INSULIN INFUSION PUMP LZG ANIMAS CORPORATION

    Patients

    Seq Age Sex Outcome Treatment
    1 40 YR