BEUDAMED
    FDA Adverse Event Death Summary report: N

    ACCU-CHEK D-TRONPLUS

    MDR report key: 2231460 · Received August 25, 2011

    Report

    Report Number
    2183996-2011-02329
    Event Type
    Death
    Date Received
    August 25, 2011
    Date of Event
    June 26, 2011
    Report Date
    August 22, 2011
    Manufacturer
    ROCHE INSULIN DELIVERY SYSTEMS INC.
    Product Code
    LZG
    PMA / PMN Number
    NA
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NL
    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. NO PRODUCT WILL BE RETURNED FOR EVAL.

    Description of Event or Problem · 1

    THE PT WAS FOUND DEAD IN HER HOME ON (B)(6) 2011. THE CAUSE OF DEATH WAS HYPOGLYCEMIA. SHE WAS SERIOUSLY ILL AND IT IS BELIEVED THAT SHE WAS ASSISTED IN USING THE INFUSION DEVICE TO COMMIT SUICIDE. THE INFUSION DEVICE WAS CONFISCATED BY POLICE AND A FORENSIC INVESTIGATION IS ONGOING TO RULE OUT MALFUNCTION OF THE DEVICE. NO PT INFO WAS PROVIDED AND THE SERIAL NUMBER OF THE INFUSION DEVICE IS UNK. NO PRODUCT WILL BE RETURNED 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 Death INSULIN INFUSION SET| INSULIN