BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ONETOUCHPING GLUCOSEMGMTSYSTEM

    MDR report key: 3242392 · Received July 23, 2013

    Report

    Report Number
    2531779-2013-11680
    Event Type
    Injury
    Date Received
    July 23, 2013
    Date of Event
    June 26, 2013
    Report Date
    June 27, 2013
    Manufacturer
    ANIMAS CORPORATION
    Product Code
    LZG
    PMA / PMN Number
    K080639
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    PATIENT

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE HAS BEEN RETURNED AND EVALUATED BY PRODUCT ANALYSIS ON 01/08/2014 WITH THE FOLLOWING FINDINGS: THE DAILY INSULIN DELIVERY TOTALS APPEARED TO BE INCONSISTENT DUE TO TIME/DATE ISSUE. A REVIEW OF THE BLACK BOX HISTORY REVEALED MULTIPLE INSTANCES OF THE TIME AND DATE DEFAULTING TO FACTORY SETTINGS FOLLOWED BY A POWER ON RESET. THE TIME AND DATE WAS FOUND TO BE MANUALLY SET TO 12AM ON (B)(6) 2013 AND WAS MANUALLY SET TO 5:02PM (B)(6) 2013. THE PUMP WAS EXERCISED FOR 29 HOURS WITH NO DELIVERY ISSUES. UNRELATED TO THE COMPLAINT, THE PUMP OPENED AND THERE WAS INTERNAL BATTERY FAILURE. 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. 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. 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.

    Description of Event or Problem · 1

    ON (B)(6) 2013, THE REPORTER CONTACTED ANIMAS STATING ON (B)(6) 2013 THE PATIENT EXPERIENCED A BLOOD GLUCOSE (BG) VALUE OF 498MG/DL WITH DIZZINESS AND HEART PALPITATIONS. THE PATIENT¿S HEART REPORTEDLY WAS RACING. THE PATIENT REPORTEDLY CHANGED OUT THE SITE/SET ON (B)(6) 2013 AND DENIED HAVING ANY ISSUES. IT WAS NOTED THAT THE SITE/SET WAS REPLACED EVERY 2 DAYS; THE PATIENT DENIED AIR BUBBLES OR LEAKING. THE PATIENT REPORTEDLY USED THE SAME INSULIN VIAL WHEN THE SITE/SET WAS CHANGED ON (B)(6) 2013. IT WAS NOTED THAT PATIENT USED REFRIGERATED INSULIN WHEN THE CARTRIDGE WAS FILLED AND WAS NOT CYCLING THE CARTRIDGE. IT WAS NOTED PRIOR TO THE CALL WITH CUSTOMER SUPPORT (CS); THE PATIENT WAS BEING TREATED VIA INSULIN PEN. CS REVIEWED THE PUMP WITH THE PATIENT AND NO ISSUES WERE NOTED WITH THE PROGRAMMING/SETTINGS ON THE PUMP. NO DELIVERY ISSUES WERE NOTED WITH THE PUMP. PUMP HISTORY INDICATED THAT THE TOTAL DAILY DOSE ADDED UP CORRECTLY. THE PATIENT REPORTEDLY WAS ABLE TO SUCCESSFULLY PERFORM AN AIR BOLUS WITH THE PUMP AT THE TIME OF TROUBLESHOOTING. THE PATIENT WAS NOT IMPLICATING THE PUMP. THIS COMPLAINT IS BEING REPORTED BECAUSE THE PATIENT EXPERIENCED A HYPERGLYCEMIC EVENT WHILE USING INSULIN PUMP THERAPY. USE ERROR CONTRIBUTED TO THE REPORTED EVENT BECAUSE THE PATIENT WAS USING THE SAME INSULIN, WAS NOT CYCLING CARTRIDGES APPROPRIATELY, WAS USING COLD INSULIN AND ALSO HAD PULLED THE INFUSION SET OUT OF THE SITE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    344213 ONETOUCHPING GLUCOSEMGMTSYSTEM INSULIN INFUSION PUMP LZG ANIMAS CORPORATION

    Patients

    Seq Age Sex Outcome Treatment
    1 14 YR Life Threatening