BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACCU-CHEK ® SPIRIT

    MDR report key: 3030194 · Received April 2, 2013

    Report

    Report Number
    2183996-2013-00553
    Event Type
    Malfunction
    Date Received
    April 2, 2013
    Date of Event
    February 18, 2013
    Report Date
    July 11, 2013
    Manufacturer
    ROCHE DIABETES CARE AG
    Product Code
    LZG
    PMA / PMN Number
    K060876
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WI, US
    Reporter Occupation
    PATIENT

    Narratives

    Additional Manufacturer Narrative · 1

    CONCLUSION THE COMPLAINT CANNOT BE VERIFIED, THE PRODUCTION DATA SHOWS NO DEVIATIONS OF THE SPECIFICATIONS. RESULT PUMP: AS THE PUMP HAS NOT BEEN RETURNED FOR INVESTIGATION AND THE PRODUCTION DATA COMPLY WITH THE SPECIFICATION, THE COMPLAINT COULD NOT BE REPLICATED. PRODUCTION REPORTS WERE REVIEWED. ADAPTER: NO ADAPTER WAS RECEIVED FOR INVESTIGATION. CARTRIDGE: THE RECEIVED USED CARTRIDGE WAS VISUALLY, LEAK AND GLIDE FORCE TESTED. CARTRIDGE PASSED THE VISUAL TEST AND THE LEAKAGE TEST AT DIFFERENT POSITIONS OF THE PLUNGER ROD. THE GLIDE FORCE MEASURED IS IN ACCORDANCE WITH PRODUCT SPECIFICATIONS. INFUSION SET: THE RETURNED USED HEAD SET AND TRANSFER SET WERE VISUALLY INSPECTED AND TESTED FOR FLOW AND TIGHTNESS. THE TEST RESULTS WERE WITHIN SPECIFICATIONS. THE PRODUCT HAS NOT RETURNED FOR EVALUATION, THE COMPLAINT COULD NOT BE INVESTIGATED.

    Additional Manufacturer Narrative · 1

    IT WAS UNKNOWN IF THE INITIAL REPORTER SENT A REPORT TO THE FDA.

    Description of Event or Problem · 1

    ON (B)(6) 2013 PATIENT REPORTED THE PISTON ROD ON THE INFUSION DEVICE IS MAKING A GRINDING NOISE AND TAKES A VERY LONG TIME TO RETURN. PATIENT STATED HE THINKS THE WEAK PISTON ROD IS AFFECTING HIS INSULIN DELIVERY. PATIENT REPORTED HE HAS ALREADY TRIED A NEW BATTERY. PATIENT STATED WHEN HE IS RETURNING THE PISTON ROD DURING THE CHANGE THE CARTRIDGE PROCESS IT CAN TAKE UP TO AN HOUR TO RETURN THE PISTON ROD. PATIENT REPORTED HE DOES NOT RECEIVE AN ERROR MESSAGE AND EVENTUALLY THE PISTON ROD RETURNS AND HE CAN CONTINUE USING THE INFUSION DEVICE. PATIENT STATED HE HAS ALREADY CHANGED THE BATTERY COVER. PATIENT REPORTED WHILE THE PISTON ROD IS REWINDING, IT MAKES A GRINDING SOUND AND HE STATES IT SOUNDS LIKE THE MOTOR IS WEAK. PATIENT STATED THE PISTON ROD IS NOT CRACKED, LOOSE OR DAMAGED. PATIENT REPORTED HE HAS HAD THIS CONCERN SINCE JANUARY, BUT RECENTLY HE THINKS THE WEAK PISTON ROD IS CAUSING THE INFUSION DEVICE TO NOT DELIVER INSULIN CORRECTLY. PATIENT STATED HIS BLOOD GLUCOSE LEVEL HAS BEEN RUNNING AROUND 350 MG/DL OR HIGHER FOR THE PAST 2-3 WEEKS. PATIENT'S NORMAL BLOOD GLUCOSE LEVEL IS 160 MG/DL. PATIENT REPORTED HE IS ABLE TO SELF-TREAT USING THE INFUSION DEVICE. PATIENT STATED HE INCREASED HIS BASAL RATE AND THE ELEVATED BLOOD GLUCOSE LEVEL CONTINUED. PATIENT REPORTED HE WILL DELIVER A LARGE BOLUS AND THE BOLUS WILL ONLY BARELY BRING DOWN HIS BLOOD GLUCOSE LEVEL FOR A SMALL AMOUNT OF TIME BEFORE THEY GO BACK UP AGAIN. THE PATIENT DID NOT REQUIRE ASSISTANCE FROM A HEALTHCARE PROFESSIONAL OR SECOND PARTY TO ADDRESS THE ISSUE. REQUESTED RETURN OF THE ALLEGED INFUSION DEVICE, CARTRIDGE, INFUSION SET AND ADAPTER FOR EVALUATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    134315 ACCU-CHEK ® SPIRIT INSULIN INFUSION PUMP LZG ROCHE DIABETES CARE AG NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1 034 YR HUMALOG