BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACCU-CHEK SPIRIT

    MDR report key: 2070367 · Received April 18, 2011

    Report

    Report Number
    2183996-2011-01093
    Event Type
    Malfunction
    Date Received
    April 18, 2011
    Date of Event
    March 18, 2011
    Report Date
    March 23, 2011
    Manufacturer
    ROCHE INSULIN DELIVERY SYSTEMS INC.
    Product Code
    LZG
    PMA / PMN Number
    K060876
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WV, US
    Reporter Occupation
    UNKNOWN

    Narratives

    Description of Event or Problem · 1

    ON (B)(6) 2011, HUSBAND REPORTED THE INFUSION DEVICE DISPLAYED A7 TEMPORARY BASAL RATE OVER 3 TIMES OVER THE LAST FEW DAYS, AND HUSBAND AND THE PT HAD NOT PROGRAMMED A TEMPORARY BASAL RATE. THE INFUSION DEVICE HISTORY WAS VERIFIED, AND THERE WERE 3 ALERTS ALONG WITH 5 DOCUMENTED TEMPORARY BASAL RATE INCREASES OF 200%. HUSBAND AND PT WERE ADVISED ON HOW TEMPORARY BASAL RATES ARE PROGRAMMED. HUSBAND REPORTED PT EXPERIENCED HYPOGLYCEMIA OF 62 MG/DL ON (B)(6) 2011 AND 46 MG/DL ON A DIFFERENT OCCASION AS A RESULT OF THE INACCURATE INSULIN DELIVERY. NORMAL BLOOD GLUCOSE IS 100-160 MG/DL, AND PT TREATED HYPOGLYCEMIA BY DRINKING JUICE OR SODA. CLINICAL TRAINER PROVIDED FOLLOW-UP ON (B)(4) 2011 AND REPORTED SHE IS CONFIDENT WITH HUSBAND AND PT'S ABILITY TO OPERATE THE INFUSION DEVICE. CLINICAL TRAINER SCHEDULED AN APPOINTMENT TO REVIEW PT'S CONCERN. ON (B)(6) 2011, HUSBAND REPORTED THE INFUSION DEVICE CONTINUED TO DISPLAY A7 TEMPORARY BASAL RATE OVER ALERTS WHEN THE CLINICAL TRAINER WAS PRESENT. PT SWITCHED TO HER BACKUP INFUSION DEVICE. INFUSION DEVICE WAS NOT EXPOSED TO WATER OR DROPPED. INFUSION DEVICE WAS REPLACED AND REQUESTED FOR EVAL. THE PT DID NOT REQUIRE ASSISTANCE FROM A HEALTHCARE PROFESSIONAL OR SECOND PARTY TO ADDRESS THE ISSUE.

    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 64 YR INSULIN INFUSION SET| INSULIN