BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACCU-CHEK ® SPIRIT

    MDR report key: 3052330 · Received April 11, 2013

    Report

    Report Number
    2183996-2013-00651
    Event Type
    Malfunction
    Date Received
    April 11, 2013
    Date of Event
    February 24, 2013
    Report Date
    June 10, 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
    CA, US
    Reporter Occupation
    PATIENT

    Narratives

    Additional Manufacturer Narrative · 1

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

    Additional Manufacturer Narrative · 1

    CONCLUSION THE COMPLAINT CANNOT BE VERIFIED DUE TO CARELESS HANDLING OF THE PRODUCT. RESULT DELIVERY ACCURACY: THE DELIVERY ACCURACY OF THE INSULIN PUMP WAS TESTED WITHIN THE PUMP DRIVE TEST ON THE DIAGNOSTIC TEST SYSTEM AND MEETS THE SPECIFICATIONS. FURTHER FINDINGS: THE SOFT COMPONENTS OF THE HOUSING ARE WORN DOWN HEAVILY. THEREFORE MOISTURE ENTERS THE INSULIN PUMP AND DESTROYS THE PUMP ELECTRONICS. CONSUMABLES THE ADAPTER PASSED THE OPTICAL INSPECTION. THE PROBLEM MENTIONED BY THE CUSTOMER IS RELATED TO CARELESS HANDLING OF THE PRODUCT.

    Description of Event or Problem · 1

    ON (B)(6) 2013, PATIENT REPORTED EXPERIENCING ELEVATED BLOOD GLUCOSE LEVELS OVER THE LAST COUPLE OF MONTHS. PATIENT STATED SHE CHANGED HER INFUSION SET TO AN UNUSED AREA IN THE LOWER BACK AND BOLUSED 3 UNITS OF INSULIN TO REDUCE THE 295 MG/DL BLOOD GLUCOSE LEVEL. PATIENT REPORTED HER BLOOD GLUCOSE BEGAN TO REDUCE BACK TO HER NORMAL RANGE. PATIENT'S NORMAL BLOOD GLUCOSE RANGE IS 100-130 MG/DL. NO OUTSIDE ASSISTANCE WAS REQUIRED. REVIEWED WITH PATIENT OTHER INFUSION SITE LOCATIONS. PATIENT WAS ABLE TO TROUBLESHOOT ON HER OWN PRIOR TO THE CALL AND WAS ABLE TO SEE INSULIN FLOWING OUT OF THE END OF THE INFUSION SET TUBING DURING A BOLUS. PATIENT STATED SHE FEELS HER SITE ABSORPTION IS CAUSING THE ISSUE. ADVISED TO CONSULT WITH HER HCP REGARDING SITE ABSORPTION. ON CALL BACK ON (B)(6) 2013 PATIENT REPORTED HER BLOOD GLUCOSE LEVELS REMAIN ELEVATED. PATIENT STATED SHE BEGAN HAVING SPORADIC ELEVATED BLOOD GLUCOSE LEVELS A COUPLE OF MONTHS AGO BUT NOW HER BLOOD GLUCOSE IS CONSISTENTLY HIGH. ASSISTED PATIENT WITH SWITCHING TO HER BACKUP INFUSION DEVICE. ON CALL BACK ON (B)(6)2013 PATIENT REPORTED HER BLOOD GLUCOSE LEVELS HAVE COME BACK DOWN TO NORMAL SINCE CHANGING OVER TO THE BACKUP INFUSION DEVICE. PATIENT STATED SHE WANTED TO CHANGE BACK TO THE PRIMARY INFUSION DEVICE AND CONTINUE TROUBLESHOOTING THE CONCERN. ON CALL BACK PATIENT REPORTED SHE IS STILL ON THE BACKUP INFUSION DEVICE. PATIENT STATED SHE FEELS IT IS THE INFUSION DEVICE BECAUSE WHEN SHE CHANGED OVER TO THE BACKUP INFUSION DEVICE HER BLOOD GLUCOSE LEVELS CAME DOWN RIGHT AWAY. NO OUTSIDE ASSISTANCE WAS NEEDED. PATIENT HAS DISCARDED THE CARTRIDGE AND INFUSION SET. 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 INFUSION DEVICE AND ADAPTER FOR EVALUATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    156109 ACCU-CHEK ® SPIRIT INSULIN INFUSION PUMP LZG ROCHE DIABETES CARE AG NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1 072 YR HUMALOG| ESTRADIOL| AMLODIPINE| TRIAMTERENE-HCTZ| LOSARTAN| ATORVASTATIN| PROVERA