BEUDAMED
    FDA Adverse Event Death Summary report: N

    ACCU-CHEK SPIRIT

    MDR report key: 911619 · Received September 11, 2007

    Report

    Report Number
    2183996-2007-01367
    Event Type
    Death
    Date Received
    September 11, 2007
    Date of Event
    August 16, 2007
    Report Date
    August 29, 2007
    Manufacturer
    DISETRONIC MEDICAL SYSTEMS, INC.
    Product Code
    LZG
    PMA / PMN Number
    K042887
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SW
    Reporter Occupation
    UNKNOWN

    Narratives

    Additional Manufacturer Narrative · 1

    THIS INCIDENT OCCURRED OUTSIDE OF 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 SUPPLEMENT REPORT.

    Description of Event or Problem · 1

    IN 2007, THE PT WAS FOUND ON THE FLOOR BY HIS WIFE. HIS BLOOD GLUCOSE MEASURED 1.6 MMOL/L (29 MG/DL). THE PT WAS GIVEN GLUCOSE INJECTIONS OF 20 UNITS AND 10 UNITS. THE PT WAS THEN TRANSPORTED TO THE HOSPITAL BY AMBULANCE. HIS BLOOD GLUCOSE MEASURED 4.9 MMOL/L (88 MG/DL) UPON ARRIVAL AT THE ER, AND HE WAS GIVEN A GLUCOSE IV. AFTER 20 MINUTES, THE PT'S BLOOD GLUCOSE ELEVATED TO 5.1 MMOL/L (92 MG/DL). AFTER 20 MINUTES, THE PT'S BLOOD GLUCOSE ELEVATED TO 9.1 MMOL/L (164 MG/DL) AND HE WAS TAKEN OFF OF THE GLUCOSE IV. ONE HOUR LATER, THE PT'S BLOOD GLUCOSE MEASURED 12.3 MMOL/L (221 MG/DL) AND HE WAS RECONNECTED TO HIS INFUSION DEVICE. THE PT'S BLOOD GLUCOSE CONTINUED TO ELEVATE TO 16.3 MMOL/L (293 MG/DL). THE PT'S BASAL RATES WERE LOWERED FROM 22.5 TO 20.5. THE PT WAS RELEASED FROM THE HOSPITAL AND THEN REPORTED ON FOUR DAYS LATER THAT HIS BLOOD GLUCOSE WAS SLIGHTLY ELEVATED. NOTES TAKEN FROM THE PT'S PHYSICIAN ON TWO DAYS LATER, INDICATE THAT THE PT HAD BEEN FEELING DIZZY FOR A COUPLE OF DAYS AND HAD SHORTNESS OF BREATH. ONE DAY EARLIER, HE BEGAN VOMITING. ON THE FOLLOWING DAY, THE PT'S FAMILY CALLED FOR AN AMBULANCE AND HE WAS GIVEN AN INHALANT TO ASSIST WITH BREATHING. THE PT'S BLOOD GLUCOSE MONITOR MEASURED "HHH" (GREATER THAN 25 MMOL/L OR 450 MG/DL). THE DOCTOR'S NOTES INDICATE THAT THE PT SMELLED OF ACETONE. AT 9:55 PM, THE PT STOPPED BREATHING. THE PT WAS PRONOUNCED DEAD AT 10:20PM AND THE INFUSION DEVICE WAS REMOVED FROM THE BODY. THE CAUSE OF DEATH WAS LISTED AS DIABETES MELLITUS TYPE 1 WITH ACIDOSIS OR HYPEROSMOLARITY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ACCU-CHEK SPIRIT INSULIN INFUSION PUMP LZG DISETRONIC MEDICAL SYSTEMS, INC. ACCU-CHEK SPIRIT NA

    Patients

    Seq Age Sex Outcome Treatment
    1 YR Death INSULIN INFUSION SET| INSULIN