BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ACCU-CHEK SPIRIT

    MDR report key: 1686325 · Received May 10, 2010

    Report

    Report Number
    2183996-2010-00921
    Event Type
    Injury
    Date Received
    May 10, 2010
    Date of Event
    April 13, 2010
    Report Date
    April 14, 2010
    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
    NJ, US
    Reporter Occupation
    UNKNOWN

    Narratives

    Additional Manufacturer Narrative · 1

    NO PRODUCT WILL BE RETURNED FOR EVALUATION.

    Description of Event or Problem · 1

    ON (B) (6) 2010, PT REPORTED HE RECEIVED AN ELEVATED BLOOD GLUCOSE TODAY. PT STATED HIS BLOOD GLUCOSE WAS 233 MG/DL ON (B) (6) 2010; WAS ABLE TO BOLUS AS NORMAL. PT REPORTED HIS BLOOD GLUCOSE RANGED FROM 191-246 MG/DL TODAY WITH HIS LAST READING BEING 211 MG/DL; HAS NOT TAKEN A CORRECTION BOLUS FOR THE LAST READING YET. PT REPORTED HE HEARD AN ERROR ALERT EARLIER AND WAS NOT CERTAIN IF IT WAS TODAY OR YESTERDAY. CHECKED HISTORY AND PT RECEIVED AN E1 (CARTRIDGE EMPTY) ALERT PRIOR TO THIS CALL. REVIEWED WITH PT WHY THIS ALERT OCCURS. PT STATED HE REPORTED THE ALERT TO HIS NURSE. PT REPORTED HE THOUGHT HE ALSO RECEIVED AN A8 (BOLUS CANCELLED) ALERT. REVIEWED THE CAUSES. PT WAS ABLE TO REPROGRAM THE BOLUS AND DELIVER THE REMAINDER OF THE BOLUS. PT STATED HE CHANGED HIS INFUSION SET AND INFUSION TUBING TODAY; HAS NOT CHANGED THE INFUSION ADAPTER YET. REVIEWED WITH PT THAT ADAPTER SHOULD BE CHANGED WITH EVERY 10TH CARTRIDGE CHANGE. TROUBLESHOOTING DID NOT FIND ANY PRODUCT ISSUES. PT WILL CHANGE TO NEW INSULIN CARTRIDGE. THE PT DID NOT REQUIRE ASSISTANCE FROM A HEALTHCARE PROFESSIONAL OR SECOND PARTY TO ADDRESS THE ISSUE. 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 53 YR INSULIN| NSULIN INFUSION SET