BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ONETOUCHPING GLUCOSEMGMTSYSTEM

    MDR report key: 3457671 · Received November 8, 2013

    Report

    Report Number
    2531779-2013-20069
    Event Type
    Injury
    Date Received
    November 8, 2013
    Report Date
    October 25, 2013
    Manufacturer
    ANIMAS CORPORATION
    Product Code
    LZG
    PMA / PMN Number
    K080639
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TN, US
    Reporter Occupation
    PATIENT

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE HAS BEEN RETURNED AND EVALUATED BY PRODUCT ANALYSIS ON 02/04/2014 WITH THE FOLLOWING FINDINGS: DURING INVESTIGATION, THE PUMP POWERED ON TO THE VERIFY SCREEN WITH AUDIBLE AND VIBRATORY FEATURES. NO ERRORS OR ALARMS ASSOCIATED WITH THE COMPLAINT WERE OBSERVED IN ALARM HISTORY. THE TOTAL DAILY DOSES ADDED UP CORRECTLY AND REFLECTED THE USER¿S PROGRAMMED BASAL RATES. AN ¿EZPRIME¿ SEQUENCE WAS SUCCESSFULLY COMPLETED WITH NO ERRORS. THE PUMP WAS EXERCISED FOR 24 HOURS WITH NO ALARMS OR WARNINGS OCCURRING. THE PUMP SUCCESSFULLY COMPLETED A DELIVERY ACCURACY TEST. DURING TESTING, THE FORCE SENSOR CALIBRATION WAS FOUND TO BE OUT OF SPECIFICATIONS. THE FORCE SENSOR RESISTANCE WAS FOUND TO BE WITHIN SPECIFICATIONS. NO CONTAMINATION WAS OBSERVED ON THE FORCE SENSOR COMPONENTS. THE PUMP HAD BEEN SUBJECTED TO CONDITIONS OUTSIDE SPECIFICATIONS.

    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.

    Description of Event or Problem · 1

    ON (B)(6) 2013, THE PATIENT CONTACTED ANIMAS STATING ON (B)(6) 2013 THE METER READ ¿HIGH¿. THE PATIENT REPORTEDLY WAS HOSPITALIZED ON (B)(6) 2013 AND UPON ADMISSION; THE PATIENT¿S BG WAS REPORTED TO BE 950 MG/DL. THE PATIENT REPORTEDLY WAS TREATED VIA INSULIN DRIP AND THE PATIENT¿S BG DECREASED TO A RANGE OF 160 MG/DL TO 180 MG/DL AND WAS RELEASED FROM THE HOSPITAL ON (B)(6) 2013. IT WAS NOTED AFTER THE PATIENT WAS RELEASED, A FEW HOURS LATER, THE PATIENT'S BD ELEVATED TO 400 MG/DL. THE PATIENT REPORTEDLY CORRECTED THE BG VIA THE PUMP AND THE PATIENT¿S BG CONTINUED TO ELEVATE TO 600 MG/DL. THE PATIENT REPORTEDLY CHANGED OUT THE SITE/SET AND CARTRIDGE WITH NO RESOLVE. THE PATIENT REPORTEDLY USED INSULIN VIALS WITH AN EXPIRY DATE OF (B)(6) 2013. THE PATIENT DENIED THAT THE INSULIN WAS CLOUDY OR LUMPY AND HAD STORED THE INSULIN IN AN AIR CONDITIONED ROOM. NO ISSUES WERE NOTED WITH AIR BUBBLES IN THE CARTRIDGE. IT WAS NOTED AFTER THE PATIENT USED THE NEW INSULIN, THE PATIENT¿S BG WENT DOWN TO 400 MG/DL, APPROXIMATELY 3 TO 4 HOURS LATER AROUND 3:30 AM, THE PATIENT¿S BG READ ¿HIGH¿ AGAIN. IT WAS NOTED THAT WHEN THE PATIENT AWOKE, THE PATIENT'S BG WAS 588 MG/DL. THE PATIENT REPORTEDLY TREATED THE BG VIA CORRECTION INJECTION AND THE PATIENT¿S BG WENT DOWN TO 326 MG/DL. THE PATIENT REPORTEDLY HAD DISCONNECTED FROM THE PUMP ON (B)(6) 2013. IT WAS NOTED THAT THE PATIENT HAD A BAD COUGH AND A SORE THROAT DURING AND AFTER HOSPITALIZATION. THE PATIENT REPORTEDLY HAD BEEN TO AN AMUSEMENT PARK AND WENT ON RIDES AND WAS UNAWARE THAT HE NEEDED TO DISCONNECT FROM THE PUMP PRIOR TO GETTING ON THE RIDES TO PREVENT THE PUMP BEING EXPOSED TO MAGNETS. THE PATIENT STATED THAT HE WAS UNSURE IF THE PUMP WAS EXPOSED TO ANY MAGNETS. IT WAS NOTED THE DAY BEFORE THE REPORTED EVENT, THE PATIENT¿S HANDS AND FEET HAD SWELLED AND HE HAD TAKEN MEDICATION FOR IT. THE PATIENT REPORTEDLY WAS ON DIALYSIS AND TYPICALLY ONLY URINATES IN THE MORNING. CUSTOMER SUPPORT (CS) REVIEWED THE PUMP WITH THE PATIENT AND NO ISSUES WERE NOTED WITH THE PROGRAMMING/SETTINGS ON THE PUMP. THIS COMPLAINT IS BEING REPORTED BECAUSE THE PATIENT EXPERIENCED A HYPERGLYCEMIC EVENT WHILE USING INSULIN PUMP THERAPY. ALTHOUGH, IT WAS NOT CLEAR WHAT THE CONTRIBUTING FACTORS WERE FOR THE PATIENT¿S REPORTED BG EXCURSION, THE PATIENT HAD OTHER HEALTH CONDITIONS UNRELATED TO DIABETES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    578208 ONETOUCHPING GLUCOSEMGMTSYSTEM INSULIN INFUSION PUMP LZG ANIMAS CORPORATION

    Patients

    Seq Age Sex Outcome Treatment
    1 68 YR Hospitalization| L| R