BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACCU-CHEK D-TRONPLUS

    MDR report key: 2345031 · Received October 26, 2011

    Report

    Report Number
    2183996-2011-02683
    Event Type
    Malfunction
    Date Received
    October 26, 2011
    Date of Event
    October 17, 2011
    Report Date
    October 21, 2011
    Manufacturer
    ROCHE INSULIN DELIVERY SYSTEMS INC.
    Product Code
    LZG
    PMA / PMN Number
    NA
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    UNKNOWN

    Narratives

    Additional Manufacturer Narrative · 1

    THIS INCIDENT OCCURRED OUTSIDE THE UNITED STATES. INFO CONTAINED WITHIN THIS REPORT IS ALL THAT IS AVAILABLE AT THIS TIME. IF FURTHER INFO IS OBTAINED IT WILL BE PROVIDED IN THE SUPPLEMENTAL REPORT.

    Description of Event or Problem · 1

    THE PT REPORTED THAT THE INFUSION DEVICE HAS BEEN DELIVERING TOO LITTLE INSULIN SINCE (B)(6) 2011. ON (B)(6) 2011 AT 1:30AM HIS BLOOD GLUCOSE MEASURED 380 MG/DL AND HE CHANGED THE INFUSION SET AND BOLUSED 7.5 UNITS OF INSULIN THROUGH THE INFUSION DEVICE. HIS BLOOD GLUCOSE RANGED FROM 221-414 MG/DL FROM 3:30-6:35AM DESPITE BOLUSING AND INJECTING INSULIN VIA PEN. AT 6:23AM HIS BLOOD GLUCOSE MEASURED 300 MG/DL AND HE CHANGED THE INSULIN CARTRIDGE AND INFUSION SET AND INJECTED INSULIN VIA PEN. AT 11:00AM, HIS BLOOD GLUCOSE MEASURED 95 MG/DL. HE BELIEVES THE INSULIN WAS BAD. ON (B)(6) 2011 AT 6:17AM HIS BLOOD GLUCOSE MEASURED 130 MG/DL. AT 7:00AM, HE ATE AND BOLUSED 5 UNITS OF INSULIN THROUGH THE INFUSION DEVICE. AT 10:00AM, HIS BLOOD GLUCOSE MEASURED 258 MG/DL AND HE INJECTED INSULIN VIA PEN AND WENT TO SEE HIS DIABETES SPECIALIST WHO TOOK A BLOOD SAMPLE. ON (B)(6) 2011 AT 7:00AM, HIS BLOOD GLUCOSE MEASURED 72 MG/DL AND HE ATE AND BOLUSED 7 UNITS OF INSULIN THROUGH THE INFUSION DEVICE. AT 9:46AM, HIS BLOOD GLUCOSE MEASURED 243 MG/DL. HE STATED, THAT WHILE USING THE INSULIN PEN HIS BLOOD GLUCOSE IS O.K. BUT WHILE USING THE INFUSION DEVICE IT IS NOT. HIS NORMAL BLOOD GLUCOSE LEVEL IS 100 MG/DL. THE PT DID NOT REQUIRE TREATMENT FROM A HEALTH CARE PROFESSIONAL OR SECOND PARTY TO ADDRESS THE ISSUE. THE INFUSION DEVICE WAS REPLACED AND REQUESTED TO BE RETURNED FOR EVALUATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ACCU-CHEK D-TRONPLUS INSULIN INFUSION PUMP LZG ROCHE INSULIN DELIVERY SYSTEMS INC. NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1 38 YR INSULIN INFUSION SET| INSULIN