BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACCU-CHEK SPIRIT CARTRIDGE

    MDR report key: 2063327 · Received April 11, 2011

    Report

    Report Number
    2183996-2011-00949
    Event Type
    Malfunction
    Date Received
    April 11, 2011
    Date of Event
    March 12, 2011
    Report Date
    March 12, 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
    FL, US
    Reporter Occupation
    UNKNOWN

    Narratives

    Description of Event or Problem · 1

    ON (B)(6) 2011, PATIENT'S WIFE REPORTED THE PATIENT NOTICED MOISTURE IN THE INFUSION DEVICE TODAY. WIFE STATED PATIENT'S BLOOD GLUCOSE WAS ELEVATED ON (B)(6) 2011 AND TODAY. WIFE REPORTED THE PATIENT'S BLOOD GLUCOSE LEVELS ARE NEVER THAT HIGH, SO THEY FIGURED SOMETHING WAS WRONG WITH THE INFUSION DEVICE. WIFE STATED THE PATIENT NOTICED MOISTURE INSIDE THE CARTRIDGE COMPARTMENT. VERIFIED IT WAS JUST MOISTURE, AND NOT ENOUGH TO POUR OUT. WIFE REPORTED THE PATIENT REMOVED THE INSULIN CARTRIDGE FROM THE INFUSION DEVICE AND IT LOOKED LIKE THE CARTRIDGE WAS LEAKING. WIFE STATED THE PATIENT BELIEVES IT WAS LEAKING FROM THE BOTTOM, AND NOT AROUND THE LUER LOCK CONNECTION. WIFE REPORTED THE INFUSION ADAPTER WAS LAST CHANGED ABOUT A YEAR AGO. ADVISED TO CHANGE WITH EVERY 10TH CARTRIDGE CHANGE. WIFE STATED PATIENT'S BLOOD GLUCOSE WAS RUNNING AROUND 500 MG/DL YESTERDAY AND TODAY. PATIENT'S TARGET BLOOD GLUCOSE RANGE IS 80-120 MG/DL. PATIENT HAS SWITCHED TO HIS BACKUP INFUSION DEVICE. WIFE REPORTED THE PATIENT PLACED A NEW INSULIN CARTRIDGE AND NEW INFUSION ADAPTER IN THE BACKUP INFUSION DEVICE. ADVISED TO LET THE PRIMARY INFUSION DEVICE DRY OVERNIGHT. ON CALL BACK ON (B)(6) 2011, PATIENT'S WIFE REPORTED THE PATIENT SWITCHED TO THE BACKUP INFUSION DEVICE YESTERDAY AND HIS BLOOD GLUCOSE LEVELS RETURNED TO NORMAL. WIFE STATED THE PATIENT WENT BACK ON THE PRIMARY INFUSION DEVICE AND HIS BLOOD GLUCOSE STARTED TO GO BACK UP AND IT REACHED 500 MG/DL AGAIN. WIFE REPORTED THE PATIENT SWITCHED BACK TO THE BACKUP INFUSION DEVICE AND IT REGULATED HIS BLOOD GLUCOSE LEVELS. THE PATIENT DID NOT REQUIRE ASSISTANCE FROM A HEALTHCARE PROFESSIONAL OR SECOND PARTY TO ADDRESS THE ISSUE. PRODUCT WAS REPLACED AND REQUESTED RETURN OF THE ALLEGED PRODUCT FOR EVALUATION.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 72 YR INSULIN| INSULIN INFUSION SET