BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACCU-CHEK SPIRIT ADAPTER

    MDR report key: 2253764 · Received August 10, 2011

    Report

    Report Number
    2183996-2011-02164
    Event Type
    Malfunction
    Date Received
    August 10, 2011
    Date of Event
    July 19, 2011
    Report Date
    July 20, 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
    AR, US
    Reporter Occupation
    UNKNOWN

    Narratives

    Additional Manufacturer Narrative · 1

    METHOD AND RESULT - NO PRODUCT WILL BE RETURNED FOR EVAL.

    Description of Event or Problem · 1

    ON (B)(6) 2011, PT REPORTED THAT SHE HAS EXPERIENCED ELEVATED BLOOD GLUCOSE SINCE (B)(6) 2011. BLOOD GLUCOSE WAS IN THE 300 MG/DL RANGE ON (B)(6) 2011 AND WAS 580 MG/DL WHEN SHE WOKE ON (B)(6) 2011. PT DELIVERED BOLUSED, AND BLOOD GLUCOSE DECREASED OVER THE NEXT 6 HOURS. BLOOD GLUCOSE WAS "FINE" THE NIGHT BEFORE THE REPORT, BUT PT WAS ABLE TO SMELL INSULIN. SHE DID NOT CHECK TO SEE IF THERE WAS INSULIN LEAKAGE, AND BLOOD GLUCOSE ELEVATED TO 532 MG/DL ON THE MORNING OF THE REPORT. PT REPORTED THE CARTRIDGE HAS HAD MOISTURE ON IT FOR SEVERAL WEEKS AND WAS "DAMP LIKE IT WAS SWEATING," BUT SHE DID NOT SEE ANY LEAKS IN THE SYSTEM. NO ERROR MESSAGES WERE RECEIVED ON THE INFUSION DEVICE. SHE CHANGES THE CARTRIDGE AND INFUSION SET EVERY 4-5 DAYS, AND THE ADAPTER WAS CHANGED ON THE DAY OF THE REPORT. INSULIN DOES NOT WARM TO ROOM TEMPERATURE BEFORE THE CARTRIDGE IS FILLED AND INSERTED IN THE INFUSION DEVICE. THERE ARE NO CONCERNS WITH AIR BUBBLES. INFUSION SET WAS NOT DISLODGED OR DISCONNECTED. F/U WAS COMPLETED WITH PT ON (B)(6) 2011. PT REPORTED BLOOD GLUCOSE RETURNED TO NORMAL RANGE (125-135 MG/DL) AFTER THE ADAPTER WAS CHANGED. SHE ALSO REPORTED SHE COULD NEVER SEE OR FEEL ANY LEAKS BUT WAS ABLE TO SMELL INSULIN, AND THIS RESOLVED AFTER THE ADAPTER WAS CHANGED. ADAPTER WAS DISCARDED AND WILL NOT BE RETURNED FOR EVAL. PT DID NOT REQUIRED TREATMENT FROM A HEALTH CARE PROFESSIONAL OR SECOND PARTY TO ADDRESS THE ISSUE.

    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 64 YR INSULIN INFUSION SET| INSULIN| NSULIN INFUSION DEVICE