BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ONETOUCHPING GLUCOSEMGMTSYSTEM

    MDR report key: 3152930 · Received June 8, 2013

    Report

    Report Number
    2531779-2013-07888
    Event Type
    Malfunction
    Date Received
    June 8, 2013
    Report Date
    May 9, 2013
    Manufacturer
    ANIMAS CORPORATION
    Product Code
    LZG
    PMA / PMN Number
    K080639
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    PATIENT

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE EVALUATION: THE DEVICE WAS RETURNED TO ANIMAS AND EVALUATED BY PRODUCT ANALYSIS ON (B)(4) 2013 WITH THE FOLLOWING RESULTS: TESTING CONFIRMED THE ISSUE IN THE HISTORY, BUT WAS UNABLE TO REPRODUCE IT DURING TESTING. PRIME HISTORY REVIEW SHOWS 43 U AND 38 U PRIMED ON THE REPORTED EVENT PERIOD. PUMP POWERS ¿ON¿ AND DISPLAYS ¿VERIFY¿ SCREEN, PUMP PERFORMED ¿REWIND¿ STEP CORRECTLY, A CARTRIDGE WITH 100 U WAS CORRECTLY LOADED INTO THE PUMP AND DISPLAYED ON THE SCREEN. FORCE SENSOR CALIBRATION READING IS WITHIN SPECIFICATION. THE PUMP WAS OPENED FOR EXAMINATION. NO EVIDENCE OF MOISTURE WAS FOUND INSIDE PUMP. INSPECTED THE MOTOR ASSEMBLY WITH NO DEFECT OBSERVED. NO DAMAGE OBSERVED ON THE FORCE SENSOR CIRCUIT. THE PISTON ROD MEASURED 0.289 INCH, NO DUST OR DEBRIS FOUND IN CARTRIDGE COMPARTMENT. UNRELATED TO THE COMPLAINT, THE KEYPAD RUBBER IS TORN AROUND ¿OK¿ BUTTON; ALL KEYS RESPOND APPROPRIATELY. KEYPAD WAS REMOVED FROM THE BASE, CONTAMINATION WAS OBSERVED TO ALL KEY¿S CONTACTS.

    Description of Event or Problem · 1

    ON (B)(6) 2013, THE REPORTER CONTACTED ANIMAS AND ALLEGED THAT MOM REPORTS THEY DID A SITE/SET CHANGE ON THE WAY TO SCHOOL IN THE CAR. MOM STATES SHE FIRST PUSH PRIME/REWIND/DID REWIND, LOAD STEP, CONTINUE AND GO PRIME. MOM STATES SHE DID SEE THE 5 DROPS COME OUT. MOM IS CONCERNED SINCE SHE REALIZED THAT THE PUMP SAID 43 U PRIMED; PRIME VOLUME SEEMS LARGER THAN NORMAL, MOM STATES USUALLY THE PRIME VOLUME IS 17 U. MOM STATES SHE FILLED THE CARTRIDGE TO @ 120 U. MOM STATES SHE CHANGES @ 2- 3 DAYS AND NEVER REUSES CARTS OR TUBING. MOM ALWAYS SEES THE 5 DROPS COME OUT END OF TUBING. MOM DISCONNECTED CHILD FROM PUMP, CHECKED TOTAL AMOUNT IN CARTRIDGE ON HOME SCREEN ¿ 97 U, FILLED 120 U AFTER PRIMING IT NOW HAS 95 U. REVIEW OF PRIME/REWIND SCREEN INDICATES ALL THE STEPS WERE COMPLETED. MOM STATES THE PUMP HAS GIVEN THE NO PRIME WARNING, BUT IT WAS ON (B)(6) 2013 WHEN HE WAS AT A PARTY, JUMPING AROUND ON THE TRAMPOLINE. REVIEW OF PRIME HX INDICATES 2 LARGER THAN NORMAL PRIME VOLUMES OVER THE PAST WEEK, ALSO SEVERAL LITTLE PRIME TOTALS DURING THE WEEK, SINCE MOM FOLLOWS CORRECT PROCEDURE AND IS UNSURE WHY THE VOLUME IS LARGER AND CANNOT REMEMBER IF PUMP GAVE THE NO PRIME WARRING ON THESE DAYS OR IF SHE DID NOT SEE INSULIN COME OUT AFTER PRIMING, THE PUMP WILL BE REPLACED TO HOME. PATIENT WILL CONTINUE USE OF PUMP NOW.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    254748 ONETOUCHPING GLUCOSEMGMTSYSTEM INSULIN INFUSION PUMP LZG ANIMAS CORPORATION

    Patients

    Seq Age Sex Outcome Treatment
    1 9 YR