BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ACCU-CHEK SPIRIT

    MDR report key: 2031029 · Received March 16, 2011

    Report

    Report Number
    2183996-2011-00550
    Event Type
    Injury
    Date Received
    March 16, 2011
    Date of Event
    February 27, 2011
    Report Date
    March 2, 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
    NC, US
    Reporter Occupation
    UNKNOWN

    Narratives

    Description of Event or Problem · 1

    ON (B)(6) 2011, PT REPORTED HER INSULIN INFUSION DEVICE STOPPED WORKING ON SUNDAY, (B)(6) 2011. PT STATED SHE WENT INTO CONVULSIONS AND WAS SENT TO THE HOSPITAL. PT REPORTED HER BLOOD GLUCOSE LEVEL WAS 'HI' AT NOON THEN 250 MG/DL AT 9:00 PM. PT STATED SHE DID NOT CHECK HER BLOOD GLUCOSE AGAIN BEFORE GOING TO BED. PT REPORTED SHE WENT INTO CONVULSIONS AT 2:00 AM AND HER BOYFRIEND CHECKED HER BLOOD GLUCOSE AND IT WAS 'HI'. PT STATED SHE WOKE UP IN THE ER. PT REPORTED HER BOYFRIEND HAD THE PARAMEDICS TAKEN HER TO THE HOSPITAL. PT STATED THIS HAS OCCURRED 2 OTHER TIMES AND SHE DID NOT GO TO THE HOSPITAL. HAD PT CHECK INFUSION DEVICE HISTORY. PT REPORTED THE LAST ERROR MESSAGE IN THE HISTORY OCCURRED AFTER THE INCIDENT. PT STATED SHE WAS IN THE HOSPITAL FOR 2 DAYS AND WAS GIVEN INSULIN WHILE IN THE HOSPITAL. PT REPORTED SHE DOES NOT KNOW IF THE INFUSION DEVICE OR THE INFUSION SET CAUSED THE ELEVATED BLOOD GLUCOSE. PT STATED SHE DID HAVE CONCERNS WITH THE INFUSION SETS. PT REPORTED SHE DOES NOT THINK THE INFUSION DEVICE IS WORKING AND DOES NOT KNOW WHY. PT STATED SHE DOES NOT WANT TO USE THE INFUSION DEVICE ANYMORE AND DOES NOT WANT A REPLACEMENT SENT. REQUESTED RETURN OF THE ALLEGED PRODUCT FOR EVAL.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 46 YR Hospitalization| O| R INSULIN ( DATE OF TX: (B)(6))| INSULIN INFUSION SET ((B)(6))