BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ACCU-CHEK SPIRIT

    MDR report key: 1903394 · Received November 12, 2010

    Report

    Report Number
    2183996-2010-02309
    Event Type
    Injury
    Date Received
    November 12, 2010
    Date of Event
    October 18, 2010
    Report Date
    October 20, 2010
    Manufacturer
    ROCHE INSULIN DELIVERY SYSTEMS INC.
    Product Code
    LZG
    PMA / PMN Number
    NA
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    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 REPORTED RECEIVING A LOW BLOOD GLUCOSE READING OF 49 MG/DL ON (B)(6) 2010 AT 8 PM; PT ATE. PT STATED AT 11 PM, HER BLOOD GLUCOSE READING WAS 87 MG/DL. PT REPORTED ON (B)(6) 2010 AT 1 AM, HER BLOOD GLUCOSE READING WAS 58 MG/DL; CHANGED INFUSION DEVICE TO A TEMPORARY BASAL RATE (TBR) OF 90% FOR 6 HRS. PT STATED AT 3 AM HER BLOOD GLUCOSE WAS 142 MG/DL, AND AT 7 AM HER BLOOD GLUCOSE WAS 92 MG/DL. PT REPORTED SHE THINKS THE INFUSION DEVICE DELIVERS TOO HIGH AMOUNT OF INSULIN. PT STATED SHE USED THE INFUSION TUBING FOR 7 DAYS. ADVISED PT OF RECOMMENDATION OF USAGE OF INFUSION TUBING. PT REPORTED SHE SHOWERED WITH THE INFUSION DEVICE ON; USED A SHOWER BAG. NO FURTHER INFO IS AVAILABLE. THE PT DID NOT REQUIRE ASSISTANCE FROM A HEALTHCARE PROFESSIONAL OR SECOND PARTY TO ADDRESS THE ISSUE. PRODUCT WAS REPLACED AND 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 59 YR Required Intervention INSULIN INFUSION SET| INSULIN