BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACCU-CHEK SPIRIT CARTRIDGE

    MDR report key: 2833957 · Received November 9, 2012

    Report

    Report Number
    2183996-2012-01711
    Event Type
    Malfunction
    Date Received
    November 9, 2012
    Date of Event
    October 17, 2012
    Report Date
    October 18, 2012
    Manufacturer
    ROCHE INSULIN DELIVERY SYSTEM INC.
    Product Code
    LZG
    PMA / PMN Number
    K060876
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TN, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    TERUMO BCT INTERNAL REFERENCE: (B)(4). INVESTIGATION: THE DISPOSABLE SET WAS RETURNED FOR EVALUATION. THE SET WAS INSPECTED VISUALLY. NO MANUFACTURING ASSEMBLY ISSUES NOR DEFECTS WERE FOUND. IT WAS NOTICED THAT THE RBC ADDITIVE SOLUTION FRANGIBLE WAS BROKEN, WHICH SHOULD NOT HAVE BEEN, IN THE BEGINNING STAGES OF THE POST COLLECTION PROCESS. ALSO THE WHITE CHANNEL CLAMP WAS OPEN AND THE YELLOW BYPASS CLAMP WAS CLOSED. IT'S SUSPECTED THAT THE CUSTOMER BROKE THE FRANGIBLE SEAL TOO EARLY IN THE POST COLLECTION PROCESS. THERE WERE 84 MLS OF FLUID IN THE RETURNED SET. THE DEVICE HISTORY RECORDS (DHR) WERE REVIEWED FOR THIS EVENT. THERE WERE NO EVENTS NOTED IN THE DHR THAT WOULD HAVE CONTRIBUTED TO THE EVENT EXPERIENCED BY THE CUSTOMER. ROOT CAUSE: INVESTIGATION OF THE DISPOSABLE SET SUGGESTS THAT THE LEVEL ALARM WAS THE RESULT OF THE FRANGIBLE CONNECTOR BEING BROKEN TOO EARLY IN THE PROCESS. THOUGH NOT CONCLUSIVE, BASED ON THE AVAILABLE INFORMATION, IT CANNOT BE RULED OUT THAT THE STORAGE SOLUTION WAS CONNECTED AND THE FRANGIBLE WAS BROKEN EARLIER THAN EXPECTED. THIS COULD CONTRIBUTE TO THE MULTIPLE AC DISCONNECT ERRORS, AND AS A RESULT, LEAD TO THE CHANNEL VOLUME TOO HIGH ALARM. POSSIBLE CAUSES OF THE LEUKOREDUCTION FAILURE WERE INCLUDED IN THE INITIAL REPORT FOR THIS EVENT. CORRECTIVE ACTION: AN INTERNAL CAPA HAS BEEN INITIATED TO EVALUATE REPORTS OF ELEVATED WBC COUNTS.

    Description of Event or Problem · 1

    ON (B)(6) 2012, PATIENT REPORTED EXPERIENCING CONCERNS WITH ELEVATED BLOOD GLUCOSE LEVELS, LEAKY CARTRIDGE AND POOR ABSORPTION. PATIENT STATED THE LEAKING OCCURRED DURING USE. PATIENT STATED SHE NOTICED MOISTURE IN THE CARTRIDGE COMPARTMENT THAT SMELLED LIKE INSULIN WHEN SHE REMOVED THE CARTRIDGE. PATIENT REPORTED THERE WAS INSULIN INSIDE OF THE INFUSION DEVICE AND THE LEAK WAS NOT AT THE LUER, CONNECTORS OR TUBING. PATIENT STATED THE LEAK ORIGINATED IN THE INSULIN CARTRIDGE AND SHE ALSO HAD LEAKING AT THE INFUSION SITE. PATIENT REPORTED HER BLOOD GLUCOSE LEVEL WAS ELEVATED BECAUSE OF THE LEAK AND POOR ABSORPTION. PATIENT STATED HER HIGH BLOOD GLUCOSE LEVEL WAS 281 MG/DL AND SHE SELF-TREATED WITH A BOLUS. PATIENT'S NORMAL BLOOD GLUCOSE LEVEL IS 120 MG/DL. PATIENT REPORTED SHE WAS ABLE TO SELF-TREAT WITHOUT ANY OUTSIDE ASSISTANCE. PATIENT STATED THERE WERE NO ALERTS ON THE INFUSION DEVICE AND SHE HAS HAD ELEVATED BLOOD GLUCOSE LEVELS FOR ABOUT A WEEK. PATIENT REPORTED SHE HAS NEVER CHANGED THE INFUSION ADAPTER. ADVISED TO CHANGE THE ADAPTER WITH EVERY 10TH CARTRIDGE CHANGE. PATIENT STATED INSULIN IS AT ROOM TEMPERATURE WHEN FILLING THE CARTRIDGE AND SHE OCCASIONALLY HAS AIR BUBBLES WHEN FILLING THE CARTRIDGES; SHE TAPS THE SIDE TO GET AIR BUBBLES TO THE TOP OT THE CARTRIDGE AND THEN PRIMES THEM OUT THROUGH THE TUBING. PATIENT REPORTED THE INFUSION SET HAS BECOME DISLODGED DUE TO POOLING AT THE SITE AND HAS HAD A LEAK AT THE SITE DUE TO POOR ABSORPTION. PATIENT STATED SHE HAS A LOT OF SCAR TISSUE. PATIENT HAS A BACKUP INFUSION DEVICE. THE PATIENT DID NOT REQUIRE ASSISTANCE FROM A HEALTHCARE PROFESSIONAL OR SECOND PARTY TO ADDRESS THE ISSUE. ON FOLLOW UP CALL ON (B)(6) 2012 PATIENT REPORTED SHE IS STILL HAVING CONCERNS WITH ABSORPTION. PATIENT STATED HER BLOOD GLUCOSE LEVEL WAS HIGHER FOR THE PAST 2 MORNINGS AND HAS HAD POOLING AT THE INFUSION SITE. ADVISED MOVING TO A SITE SHE HAS NEVER USED BEFORE. PRODUCT WAS REPLACED AND REQUESTED RETURN OF THE ALLEGED INFUSION SET, ADAPTER AND INSULIN CARTRIDGE FOR EVALUATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ACCU-CHEK SPIRIT CARTRIDGE LZG ROCHE INSULIN DELIVERY SYSTEM INC. NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 58 YR DATE OF THERAPY: UNK| RELATED ACCESSORIES| INSULIN| INSULIN INFUSION PUMP