BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ACCU-CHEK SPIRIT

    MDR report key: 2171094 · Received July 8, 2011

    Report

    Report Number
    2183996-2011-01989
    Event Type
    Injury
    Date Received
    July 8, 2011
    Date of Event
    June 21, 2011
    Report Date
    June 24, 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

    Additional Manufacturer Narrative · 1

    NO PRODUCT WILL BE RETURNED FOR EVAL.

    Description of Event or Problem · 1

    ON (B)(6) 2011, CDE REPORTED THE PT WAS ADMITTED INTO THE HOSPITAL ON TUESDAY (B)(6) 2011. CDE STATED THE PT WAS ADMITTED WITH A BLOOD GLUCOSE LEVEL AS HIGH AS 600 MG/DL. PT'S NORMAL BLOOD GLUCOSE RANGE IS 140 MG/DL. CDE REPORTED THE PT WAS FEELING ILL AND BAD AND THEN WENT UNCONSCIOUS. CDE STATED THE PT'S FAMILY CALLED THE EMTS. CDE REPORTED THE PT WAS GIVEN AN INSULIN DRIP AND SYRINGE INJECTIONS WHILE IN THE HOSPITAL. CDE STATED THE PT WAS TAKEN OFF OF THE INFUSION DEVICE DUE TO THE MEDICAL STAFF BEING UNFAMILIAR WITH THE INFUSION DEVICE. CDE REPORTED SHE WAS CALLED TO ASSIST THE PT WITH THE INFUSION DEVICE BEFORE BEING RELEASED FROM THE HOSPITAL ON (B)(6) 2011. CDE STATED THE PT IS USING A COMPETITOR'S INFUSION SET. CDE REPORTED SHE REVIEWED THE PT'S INFUSION DEVICE HISTORY AND THE PT WAS NOT BOLUSING WITH THE DEVICE. CDE STATED THE PT FORGOT TO PERFORM BOLUSES WITH THE INFUSION DEVICE AFTER EATING OR FOR BLOOD GLUCOSE CORRECTION. TROUBLESHOOTING DID NOT REVEAL ANY INFUSION DEVICE ISSUES. CDE REPORTED THE CLINICAL NURSE WILL BE WORKING WITH THE PT ON EDUCATION AND ASSISTING WITH PUTTING HER ON A DIFFERENT INFUSION SET. ATTEMPTS TO F/U WITH THE PT WERE UNSUCCESSFUL. NO PRODUCT RETURN WAS REQUESTED.

    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 Hospitalization| O| R INSULIN INFUSION SET (DATE OF TX: (B)(6))| INSULIN (DATE OF TX: (B)(6))