BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ACCU-CHEK SPIRIT ADAPTER

    MDR report key: 1730983 · Received June 17, 2010

    Report

    Report Number
    2183996-2010-01279
    Event Type
    Injury
    Date Received
    June 17, 2010
    Date of Event
    May 20, 2010
    Report Date
    May 20, 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
    WA, US
    Reporter Occupation
    UNKNOWN

    Narratives

    Description of Event or Problem · 1

    ON (B)(6) 2010, THE PT REPORTED EXPERIENCING ELEVATED BLOOD GLUCOSE OF 202-439 MG/DL SINCE CHANGING THE INSULIN CARTRIDGE, ADAPTER, AND INFUSION SET THE PREVIOUS DAY. HIS TARGET BLOOD GLUCOSE LEVEL IS 100 MG/DL. HE STATED, HE HAD DIFFICULTY ATTACHING THE ADAPTER TO THE INFUSION DEVICE AND IT FELT TIGHTER THAN NORMAL. HE CHANGED THE ADAPTER AND RECONNECTED TO THE INFUSION DEVICE. UPON FOLLOW UP (B)(6) 2010, HE STATED HIS BLOOD GLUCOSE DECREASED AFTER CHANGING THE ADAPTER. HE STATED, HIS BLOOD GLUCOSE ELEVATED AGAIN ON (B)(6) 2010 AND RANGED FROM 170-356 MG/DL. HE STATED, HE CHANGED THE INFUSION SITE WHEN HE WOKE UP, THE SITE HAD BEEN IN PLACE FOR 4 DAYS. HE STATED, HE ALSO DRANK JUICE BEFORE BED LAST NIGHT AND HE DID NOT BOLUS FOR IT. AT THE TIME OF THE FOLLOW UP, THE PT'S BLOOD GLUCOSE HAD RETURNED TO NORMAL. THE PT DID NOT REQUIRE MEDICAL ASSISTANCE FROM A HEALTHCARE PROFESSIONAL OR SECOND PARTY TO ADDRESS THE ISSUE. NO PRODUCT WAS REQUESTED TO BE RETURNED FOR EVALUATION.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 77 YR INSULIN INFUSION SET| INSULIN| INSULIN INFUSION PUMP