BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ONETOUCHPING GLUCOSEMGMTSYSTEM

    MDR report key: 2133051 · Received June 18, 2011

    Report

    Report Number
    2531779-2011-04262
    Event Type
    Malfunction
    Date Received
    June 18, 2011
    Report Date
    May 21, 2011
    Manufacturer
    ANIMAS CORPORATION
    Product Code
    LZG
    PMA / PMN Number
    K080639
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). DEVICE EVALUATION: THE PUMP HAS BEEN RETURNED AND EVALUATED BY PRODUCT ANALYSIS ON (B)(4) 2011 WITH THE FOLLOWING FINDINGS: A REVIEW OF THE PUMP TOTAL DAILY DOSE HISTORY FROM (B)(6) 2011 TO END OF PUMP USE ON (B)(6) 2011 CONFIRMED THAT DAILY INSULIN DELIVERY TOTALS CORRECTLY REFLECTS THE USERS PROGRAMMED BASAL RATES. NO ALARMS OR PUMP CONDITIONS INDICATING A MALFUNCTION WERE RECORDED IN BLACK BOX OR ALARM HISTORY. A 29 HOUR FLOW ACCURACY TEST WAS PERFORMED AND THE PUMP WAS FOUND TO BE DELIVERING WITHIN SPECIFICATIONS. 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 BEEN RETURNED TO ANIMAS; HOWEVER, THE INVESTIGATION HAS NOT BEEN COMPLETED. NO CONCLUSIONS CAN BE DRAWN AT THIS TIME. ONCE THE EVALUATION HAS BEEN COMPLETED A SUPPLEMENTAL REPORT WILL BE FILLED.

    Description of Event or Problem · 1

    THE PATIENT CONTACTED ANIMAS ALLEGING ELEVATED BLOOD GLUCOSE (BG) READINGS IN THE 250-400MG/DL RANGE THAT SHE HAS HAD TO CORRECT VIA SYRINGE TO DECREASE. THERE WAS NO MENTION OF SYMPTOMS. HOWEVER, THE PATIENT CLAIMED HER ENDOCRINOLOGIST EVALUATED THE PUMP, SITE AND SET AND ADVISED HER TO CONTACT THE MANUFACTURER TO GET THE PUMP REPLACED. AT THE TIME OF TROUBLESHOOTING, THE PATIENT REPORTED THAT THE PUMP IS NO LONGER MAKING MOTOR NOISE WHEN BOLUS IS DELIVERED. THE PATIENT DENIED SITE ISSUES AND REPORTEDLY HAS CHANGED THE SITE/SUPPLIES 8X IN A THREE DAY PERIOD. THE PATIENT DENIED KINKING OR BLOOD NOTED IN THE CANNULA, NO AIR BUBBLES, NO LEAKING AT SITE, TUBING OR CARTRIDGE. THE PATIENT ALSO CONFIRMED THERE WAS NO PAIN, REDNESS OR IRRITATION AT THE SITE. IT WAS NOTED THERE WERE NO ASSOCIATED ALARMS WHEN REVIEWING THE PUMP'S ALARM HISTORY. HOWEVER, THE PATIENT STATES THAT THE HISTORY ON THE PUMP IS INCORRECT AND SHE HAS HAD TO EDIT HER BASAL RATES BECAUSE OVER THE PAST WEEK, THE 1:30PM BASAL RATE HAS RESET BACK TO 0U/HR WITHOUT USER INTERVENTION. AT THE TIME OF THE CALL, THE PUMP HISTORY SHOWED 0 BASAL FOR 1:30PM AND WHEN BASAL RATES WERE REVIEWED THE RATE WAS 0. NO INADVERTENT SUSPENDS WERE NOTED. DURING TROUBLESHOOTING, IT WAS FOUND THAT TOTAL DAILY DELIVER (TDD) AND THE BOLUS HISTORY WERE NOT ADDING UP. TDD SHOWED 28.3U DELIVERED FOR (B)(6) 2011 FOR BOLUS; HOWEVER, BOLUS HISTORY SHOWED ONLY 3 BOLUSES TOTALING 13.85U. THE PATIENT DENIED CHANGING THE TIME/DATE ON THE PUMP AND DENIED THAT THE PUMP RESET BACK TO FACTORY DEFAULT SETTINGS WITH BATTERY CHANGE. THE PATIENT DID NOT REPORT ANY BG READINGS OR SYMPTOMS THAT MEET ANIMAS CRITERIA FOR A SERIOUS INJURY. HOWEVER, THIS COMPLAINT IS BEING REPORTED BECAUSE OF THE ALLEGED ISSUE WITH THE BASAL PROGRAMMING AND DELIVERY HISTORY.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 28 YR