BEUDAMED
    FDA Adverse Event Death Summary report: N

    ACCU-CHEK D-TRONPLUS

    MDR report key: 2061356 · Received April 7, 2011

    Report

    Report Number
    2183996-2011-00829
    Event Type
    Death
    Date Received
    April 7, 2011
    Date of Event
    March 4, 2011
    Report Date
    March 8, 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
    SZ
    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'S DOCTOR REPORTED THE PT DIED IN THE TRAIN. PT'S DOCTOR STATED THE PT SUFFERED FROM A SILENT MYOCARDIAL INFARCTION. PT'S DOCTOR REPORTED ON THIS DAY THE PT HAD EXCEPTIONALLY ELEVATED BLOOD GLUCOSE, SO IT IS POSSIBLE, THAT HIS ELEVATED BLOOD GLUCOSE VALUES COULD BE IN CONNECTION WITH THE DEATH. PT'S BLOOD GLUCOSE LEVELS AND BOLUS INJECTIONS WERE REPORTED AS FOLLOWS: AT 6:20 AM PT'S BLOOD GLUCOSE LEVEL WAS 5.1 MMOL/L (92 MG/DL): BOLUS OF 6.36 UNITS OF INSULIN/HOURS AND 7.18 UNITS OF INSULIN/HOUR; AT 9:57 AM, PT'S BLOOD GLUCOSE LEVEL WAS 14.6 MMOL/L (263 MG/DL): BOLUS OF 10.02 UNITS OF INSULIN/HOURS; AT 12:55 PM, PT'S BLOOD GLUCOSE LEVEL WAS 24.5 MMOL/L (441 MG/DL): BOLUS OF 13.09 UNITS OF INSULIN/HOUR; AND AT 6:00 PM PT'S BLOOD GLUCOSE LEVEL WAS 29.0 MMOL/L (522 MG/DL): BOLUS OF 18.08 UNITS OF INSULIN/HOUR. NO FURTHER INFO IS AVAILABLE. PT'S WIFE WILL RETURN THE INFUSION DEVICE WITH THE ADAPTER AND THE INFUSION SET; NO REPLACEMENT WAS SENT.

    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