BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ONETOUCHPING GLUCOSEMGMTSYSTEM

    MDR report key: 3168269 · Received June 13, 2013

    Report

    Report Number
    2531779-2013-08193
    Event Type
    Injury
    Date Received
    June 13, 2013
    Date of Event
    May 4, 2013
    Report Date
    May 14, 2013
    Manufacturer
    ANIMAS CORPORATION
    Product Code
    LZG
    PMA / PMN Number
    K080639
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AZ, US
    Reporter Occupation
    PATIENT

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE PUMP WAS RETURNED FOR INVESTIGATION. 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. REVIEW OF THE BLACK BOX AND DOWNLOAD HISTORY REVEALED THE INSULIN DELIVERY TOTALS CORRECTLY REFLECTED THE PROGRAMMED BASAL RATES. THE BOLUS HISTORY FOR THE MORNING OF (B)(6) 2013, REVEALED A 4-UNIT BOLUS AT 5:33 AM AND A 6-UNIT BOLUS AT 9:19 AM. IN ADDITION, THE PATIENT REPORTED GIVING A 5-UNIT MANUAL INSULIN INJECTION AT 6:30 AM. THE BASAL HISTORY REVEALED THAT THE BASAL SETTINGS HAD BEEN CHANGED ON (B)(6) 2003, FROM 00:00=0.300U P/HR, 02:00=0.450U P/HR, 12:00=0.400U P/HR, 18:00=0.250U P/HR TO 00:00=0.350U P/HR, 02:00=0.500U P/HR, 05:00=0.550U P/HR, 12:00=0.450U P/HR, 18:00=0.300U P/HR. OF NOTE, A 5:00 AM BOLUS DOSE OF 0.550 UNITS/HR WAS ADDED AS PART OF THE NEW PROGRAM THAT DID NOT EXIST IN THE PREVIOUS BASAL RATE PROGRAM. ON TESTING, THE PUMP WAS EXERCISED FOR 29 HOURS AND WAS FOUND TO BE DELIVERING INSULIN AS PROGRAMMED AND WITHIN THE REQUIRED SPECIFICATIONS. INVESTIGATION DID NOT REVEAL ANY PUMP DEFECT OR MALFUNCTION.

    Description of Event or Problem · 1

    ANIMAS RECEIVED WRITTEN CORRESPONDENCE ON (B)(6) 2013, FROM THE PATIENT ALLEGING BLOOD GLUCOSE (BG) ELEVATIONS ON (B)(6) 2013, RESULTING FROM, WHAT SHE DESCRIBED AS AN ¿INEFFICIENT PUMP¿. THE PATIENT ALLEGED SHE HAD BG MEASUREMENTS AS HIGH AS 558 MG/DL ON (B)(6) 2013. THE PATIENT FURTHER REPORTED THAT AT 7:00 AM, 30 MINUTES AFTER TAKING A 5 UNIT INSULIN INJECTION FOR ALLEGED ELEVATED BG OF 448 MG/DL, SHE BECAME UNCONSCIOUS. THE PATIENT DESCRIBED ¿COMING OUT OF IT¿ AND CONSUMED ORANGE JUICE. THE PATIENT THEN REPORTED THAT HER BG ELEVATED AGAIN TO 558 MG/DL BY 12:00 PM. THE PATIENT REPORTED THAT HER BG CONTINUED TO FLUCTUATE UP AND DOWN THAT DAY UNTIL 5:00 PM. THE PATIENT STATED THAT ALL DURING THIS TIME, SHE HAD BEEN TAKING INSULIN INJECTIONS OF 4-5 UNITS. THE PATIENT ALLEGED THAT THE INSULIN PUMP WAS NOT DELIVERING INSULIN DURING THIS TIME ON (B)(6) 2013. THE PATIENT REPORTED THAT SHE HAD RETURNED THE SUBJECT PUMP TO ANIMAS AND HAS SINCE RECEIVED A REPLACEMENT PUMP. THE PATIENT REPORTED HER BG HAS BEEN WELL CONTROLLED WITHOUT ISSUE USING THE NEW PUMP. THIS COMPLAINT IS BEING REPORTED BECAUSE THE PATIENT ALLEGEDLY EXPERIENCED HYPERGLYCEMIA WHILE ON INSULIN PUMP.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    269413 ONETOUCHPING GLUCOSEMGMTSYSTEM INSULIN INFUSION PUMP LZG ANIMAS CORPORATION

    Patients

    Seq Age Sex Outcome Treatment
    1 73 YR Life Threatening| R