BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACCU-CHEK D-TRONPLUS

    MDR report key: 2022209 · Received March 11, 2011

    Report

    Report Number
    2183996-2011-00513
    Event Type
    Malfunction
    Date Received
    March 11, 2011
    Date of Event
    February 18, 2011
    Report Date
    March 6, 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

    PT REPORTED FOR THE PAST 2 WEEKS SHE HAS EXPERIENCED LOW BLOOD GLUCOSE LEVELS AS LOW AS 33 MG/DL OFTEN. PT STATED, SHE DOES NOT GIVE A BOLUS FOR MEALS BUT HER BLOOD GLUCOSE LEVEL WAS TOO LOW; PT ATE OR DRANK FOR CORRECTION. PT REPORTED SHE SWITCHED TO HER BACKUP INFUSION DEVICE THIS MORNING AND NOW HER BLOOD GLUCOSE LEVEL IS OKAY. PT'S NORMAL BLOOD GLUCOSE LEVEL IS 100 MG/DL. NO FURTHER INFO IS AVAILABLE. THE PT DID NOT REQUIRE ASSISTANCE FROM A HEALTHCARE PROFESSIONAL OR SECOND PARTY TO ADDRESS THE ISSUE. REQUESTED RETURN OF THE ALLEGED INFUSION DEVICE 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 41 YR INSULIN| INSULIN INFUSION SET