BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ACCU-CHEK SPIRIT

    MDR report key: 2421470 · Received January 12, 2012

    Report

    Report Number
    2183996-2011-03118
    Event Type
    Injury
    Date Received
    January 12, 2012
    Date of Event
    December 26, 2011
    Report Date
    December 27, 2011
    Manufacturer
    ROCHE INSULIN DELIVERY SYSTEMS INC.
    Product Code
    LZG
    PMA / PMN Number
    K060876
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    ON (B)(6) 2011, REGIONAL CLINICAL SPECIALIST (RCS) REPORTED THE PATIENT WAS ADMITTED TO THE HOSPITAL ON (B)(6) 2011 DUE TO AN ELEVATED BLOOD GLUCOSE LEVEL OF 1100 MG/DL. RCS STATED PATIENT WAS TAKEN OFF OF THE INFUSION DEVICE WHEN SHE GOT TO THE HOSPITAL AND WAS TREATED WITH AN IV OF INSULIN. RCS REPORTED ONCE THE PATIENT'S BLOOD GLUCOSE LEVEL WAS DOWN TO NORMAL SHE WAS PUT BACK ON HER INFUSION DEVICE AND THEN HER BLOOD GLUCOSE LEVEL WENT RIGHT BACK UP TO 400 MG/DL WHILE ONLY ON THE INFUSION DEVICE. RCS STATED THE PATIENT'S TRAINER CHANGED HER BASAL RATES ON (B)(6) 2011 AND DID NOT FIND ANY MALFUNCTIONS WITH THE INFUSION DEVICE AT THAT TIME. REVIEWED TRAINER'S DOCUMENTED BASAL RATE CHANGES ON CALL BACK RCS REQUESTING TO PLACE PATIENT ON BACKUP INFUSION DEVICE TO SEE IF IT WILL HELP HER BLOOD GLUCOSE LEVEL. ON FOLLOW UP CALL, PATIENT'S GRANDDAUGHTER REPORTED THE PATIENT'S NORMAL BLOOD GLUCOSE LEVEL IS IN THE 200'S MG/DL. GRANDDAUGHTER STATED THE PATIENT WAS PLACED BACK ON THE INFUSION DEVICE THIS MORNING AND THE HIGHEST HER BLOOD GLUCOSE HAS BEEN TODAY WAS 222 MG/DL, AND NOT 400 MG/DL. GRANDDAUGHTER REPORTED THE BLOOD GLUCOSE LEVEL OF 222 MG/DL IS A NORMAL READING. GRANDDAUGHTER STATED THEY ARE NOT SURE WHAT CAUSED THE PATIENT'S ELEVATED BLOOD GLUCOSE LEVEL. TROUBLESHOOTING DID NOT FIND ANY PRODUCT ISSUES. ON FOLLOW UP CALL TO THE REGIONAL CLINICAL SPECIALIST, INFORMED HER THAT PATIENT'S BLOOD GLUCOSE DID NOT GO BACK UP SINCE BEING PLACED BACK ON THE INFUSION DEVICE WHILE IN THE HOSPITAL. ON FOLLOW UP CALL ON (B)(6) 2012, PATIENT'S GRANDDAUGHTER REPORTED PATIENT WAS RELEASED FROM THE HOSPITAL ON (B)(6) 2011. GRANDDAUGHTER STATED SHE IS STILL NOT SURE WHAT CAUSED THE PATIENT'S ELEVATED BLOOD GLUCOSE LEVELS. NO PRODUCT RETURN WAS REQUESTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ACCU-CHEK SPIRIT LZG ROCHE INSULIN DELIVERY SYSTEMS INC. NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1 87 YR Hospitalization| O| R INSULIN| INSULIN INFUSION PUMP AND RELATED ACCESSORIES