BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ONETOUCHPING GLUCOSEMGMTSYSTEM

    MDR report key: 3071183 · Received April 22, 2013

    Report

    Report Number
    2531779-2013-04764
    Event Type
    Injury
    Date Received
    April 22, 2013
    Report Date
    March 25, 2013
    Manufacturer
    ANIMAS CORPORATION
    Product Code
    LZG
    PMA / PMN Number
    K080639
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MD, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). DEVICE EVALUATION: A REVIEW OF THE TOTAL DAILY DOSE HISTORY INDICATED THAT THE INSULIN DELIVERY TOTALS CORRECTLY REFLECTED PROGRAMMED VALUES. THE PUMP WAS EXERCISED FOR 29 HOURS WITH NO DELIVERY ISSUES. THE PUMP WAS EVALUATED AND FOUND TO BE OPERATING WITHIN REQUIRED SPECIFICATIONS AND DELIVERING INSULIN ACCURATELY.

    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)(4) 2013 THE PATIENT CONTACTED ANIMAS ALLEGING ELEVATED BLOOD GLUCOSE (BG) SINCE (B)(6) 2013 UP TO 600MG/DL WITH DRY MOUTH AND LETHARGY. THE PATIENT REPORTEDLY HAS BEEN CORRECTING BGS WITH SYRINGE INJECTIONS AND WITH THE PUMP, AND STATED BGS RESPOND BUT THEN WILL RAISE AGAIN. THE PATIENT'S BG PRIOR TO CONTACTING CUSTOMER TECHNICAL SUPPORT (CTS) WAS REPORTEDLY 319MG/DL. CTS REVIEWED THE PUMP WITH THE PATIENT AND FOUND ALL SETTINGS AND HISTORIES WERE CORRECT. THE PATIENT STATED THAT ON (B)(6) 2013 SHE CHANGED THE SITE THREE TIMES HOWEVER THE PRIME HISTORY INDICATES ONLY ONE SITE CHANGE ON THAT DATE. THE PATIENT STATED SHE HAS BEEN USING HER ABDOMEN FOR SITE ROTATION SINCE SHE WAS DIAGNOSED IN 2004 BUT DENIES ANY BUMPS OR SCARRING AT SKIN SITED. THE PATIENT WAS REPORTEDLY ON INSULIN PUMP THERAPY AT THE TIME OF THE CALL TO ANIMAS CTS AND STATED SHE WOULD CHANGE OUT THE SITE, SET, AND CARTRIDGE AND MONITOR BG ON THE NEW SITE. THERE WAS NO PUMP DEFECT FOUND ON TROUBLESHOOTING. THE PATIENT WAS ADVISED TO CONTACT HER HEALTHCARE PROVIDER TO DISCUSS POSSIBLE CHANGES IN DIABETES MANAGEMENT. THIS COMPLAINT IS BEING REPORTED BECAUSE THE PATIENT ALLEGEDLY EXPERIENCED HYPERGLYCEMIA OF UNKNOWN CAUSE WHILE USING INSULIN PUMP THERAPY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    170996 ONETOUCHPING GLUCOSEMGMTSYSTEM INSULIN INFUSION PUMP LZG ANIMAS CORPORATION

    Patients

    Seq Age Sex Outcome Treatment
    1 51 YR Life Threatening