BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ACCU-CHEK D-TRONPLUS

    MDR report key: 1973840 · Received January 20, 2011

    Report

    Report Number
    2183996-2010-02783
    Event Type
    Injury
    Date Received
    January 20, 2011
    Date of Event
    December 9, 2010
    Report Date
    December 21, 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. INFORMATION CONTAINED WITHIN THIS REPORT IS ALL THAT IS AVAILABLE AT THIS TIME. IF FURTHER INFORMATION IS OBTAINED, IT WILL BE PROVIDED IN THE SUPPLEMENTAL REPORT.

    Description of Event or Problem · 1

    THE PT'S DAUGHTER REPORTED THE PT HAS BEEN USING THE INFUSION DEVICE SINCE (B)(6) 2010. SHE STATED THAT WHEN THE PT BEGAN USING THE INFUSION DEVICE HE OFTEN EXPERIENCED LOW BLOOD GLUCOSE AND HE NOW HAS ERRATIC BLOOD GLUCOSE (3-40 MMOL/L, 54-720 MG/DL). THE PT EATS GLUCOSE OR INJECTS INSULIN VIA PEN TO CORRECT HIS BLOOD GLUCOSE. ON (B)(6) 2010 THE PT FELT VERY SICK AND HIS WIFE CONTACTED THE AMBULANCE. HE WAS TRANSPORTED BY AMBULANCE TO THE HOSPITAL WAS TREATED IN THE REGULAR CARE UNIT UNTIL (B)(6) 2010. NO FURTHER INFORMATION IS AVAILABLE. THE INFUSION DEVICE WAS 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 86 YR Hospitalization| O| R INSULIN (DATE OF TX: (B)(6))| (DATE OF TX: (B)(6))| INSULIN INFUSION SET