BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ACCU-CHEK D-TRONPLUS

    MDR report key: 1898073 · Received November 9, 2010

    Report

    Report Number
    2183996-2010-02277
    Event Type
    Injury
    Date Received
    November 9, 2010
    Date of Event
    October 13, 2010
    Report Date
    October 15, 2010
    Manufacturer
    ROCHE INSULIN DELIVERY SYSTEMS, INC.
    Product Code
    LZG
    PMA / PMN Number
    NA
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    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

    PATIENT REPORTED RECEIVING AN UNK ELEVATED BLOOD GLUCOSE LEVEL OF 200-260 MG/DL AT NOON ON (B)(6) 2010; TOOK CORRECTION WITH THE INFUSION DEVICE BUT BLOOD GLUCOSE LEVEL REMAINED ELEVATED. PATIENT STATED HER BLOOD GLUCOSE LEVEL WAS 354 MG/DL ON (B)(6) 2010 AT NOON; TOOK CORRECTION WITH THE INFUSION DEVICE BUT AGAIN BLOOD GLUCOSE REMAINED ELEVATED. PATIENT'S NORMAL BLOOD GLUCOSE LEVEL IS 100-120 MG/DL. PT REPORTED THAT AT APPROX 5:30PM - 6:00PM THE INFUSION DEVICE DISPLAYED AN E7 (ELECTRONIC ERROR) ALERT. PATIENT STATED SHE CHANGED HER BACKUP INFUSION DEVICE, AND THEN TOOK A CORRECTION WITH THE DEVICE. PATIENT REPORTED THE BACKUP INFUSION DEVICE HAD THE SAME BASAL RATE AS HER PRIMARY DEVICE. PATIENT STATED ON (B)(6) 2010, SHE MAY HAVE HAD THE FLU. PATIENT REPORTED HER BLOOD GLUCOSE LEVEL IS OKAY AT THIS TIME. NO FURTHER INFO IS AVAILABLE. THE PATIENT DID NOT REQUIRED ASSISTANCE FROM A HEALTHCARE PROFESSIONAL OR SECOND PARTY TO ADDRESS THE ISSUE. PRODUCT WAS REPLACED AND REQUESTED RETURN OF THE ALLEGED PRODUCT FOR EVAL.

    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 Required Intervention INSULIN| INSULIN INFUSION SET