BEUDAMED
    FDA Adverse Event Injury Summary report: N

    D-TRON PLUS

    MDR report key: 1023259 · Received March 31, 2008

    Report

    Report Number
    2183996-2008-00425
    Event Type
    Injury
    Date Received
    March 31, 2008
    Date of Event
    March 5, 2008
    Report Date
    March 26, 2008
    Manufacturer
    DISETRONIC MEDICAL SYSTEMS
    Product Code
    LZG
    PMA / PMN Number
    K043000
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    UNKNOWN

    Narratives

    Description of Event or Problem · 1

    IN 2008, THE PT REPORTED FOR ABOUT 3 WKS, "MY PUMP APPEARS TO BE DELIVERING 1.5 TO 2.0 UNITS EXTRA INSULIN IN ADDITION TO WHAT I HAVE PROGRAMMED. " SHE STATED THAT WHEN SHE PROGRAMS A BOLUS INTO HER INFUSION DEVICE SHE HAS AN IMMEDIATE DECREASE IN BLOOD GLUCOSE. SHE STATED THAT THIS TYPICALLY OCCURS AFTER SHE CHANGES HER INSULIN CARTRIDGE, ADAPTER, AND INFUSION SET. THE OVER-DELIVERY ISN'T RECORDED IN THE MEMORY OF THE INFUSION DEVICE. SHE THEN REPORTED THAT WHEN SHE REVIEWS THE BOLUS HISTORY HER MOST RECENT BOLUS IS SOMETIMES MISSING AS IF NO BOLUS WAS DELIVERED. SHE STATED THAT ON FIVE DAYS PRIOR TO ORIGINAL DATE AT 5:20PM, SHE CHANGED HER HEADSET AND BOLUSED 1.5 UNITS OF INSULIN. SHE STATED, "WITHIN 15 MINS OF PROGRAMMING A 1.5 UNIT PRIME, IT (IF INFUSION DEVICE) WAS PULSING AS IF IT WAS GIVING INSULIN." SHE STATED THE INFUSION DEVICE DELIVERED 1.5 UNITS OF INSULIN THAT SHE DID NOT PROGRAM. ON THE NEXT DAY AT 12:00 PM, THE PT PROGRAMMED A 5 UNIT BOLUS THAT DID NOT DELIVER. AT 12:30 PM HER BLOOD GLUCOSE MEASURED 8.7 MMOL/L (157 MG/DL) AND SHE BOLUSED AGAIN. SHE STATED THAT SHE "ENDED UP GETTING A DOUBLE BOLUS, AND I WENT IN AN INSULIN REACTION." HER BLOOD GLUCOSE DECREASED TO 2.8 MMOL/L (50 MG/DL) AND SHE BEGAN TO SWEAT. SHE DRANK JUICE AND ATE GLUCOSE TABLETS TO ELEVATE HER READINGS. SHE STATED THE BOLUS HISTORY ONLY LISTED BOLUSES AT 7:20 AM AND 5:00 PM. ON TWO DAYS LATER, THE PT STATED SHE WATCHED A 4.0 UNIT BOLUS DELIVER. SHE STATED THAT 10 MINS LATER SHE REVIEWED THE BOLUS HISTORY AND THE BOLUS WAS NOT LISTED. THE LAST BOLUS LISTED FOR THAT DATE WAS AT 11:20 AM. SHE STATED THAT SHE TESTED HER BLOOD GLUCOSE EVERY HALF HOUR, AND HER BLOOD GLUCOSE DECREASED EVEN THOUGH SHE HAD NOT BOLUSED ANY MORE INSULIN. THE PT REVIEWED THE BOLUS HISTORY DURING THE REPORT AND A BOLUS OF 4.0 UNITS WAS LISTED AT 5:15 PM ON THE SAME DAY. THE PT'S NORMAL BLOOD GLUCOSE RANGE IS 6-7 MMOL/L (108-126 MG/DL). THE PT DID NOT REQUIRE MEDICAL ASSISTANCE FROM A HEALTHCARE PROFESSIONAL OR SECOND PARTY TO ADDRESS THE ISSUE. PRODUCT WAS REPLACED AND REQUESTED TO BE RETURNED ON A SEPARATE RECORD.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 D-TRON PLUS INSULIN INFUSION PUMP LZG DISETRONIC MEDICAL SYSTEMS NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention INSULIN INFUSION SET| INSULIN