BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACCU-CHEK SPIRIT COMBO

    MDR report key: 3243357 · Received July 23, 2013

    Report

    Report Number
    2183996-2013-01362
    Event Type
    Malfunction
    Date Received
    July 23, 2013
    Date of Event
    June 24, 2013
    Report Date
    October 29, 2013
    Manufacturer
    ROCHE HEALTH SOLUTIONS, INC
    Product Code
    LZG
    PMA / PMN Number
    NA
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE

    Narratives

    Additional Manufacturer Narrative · 1

    CONCLUSION - THE COMPLAINT CANNOT BE VERIFIED DUE TO MISHANDLING OF THE PRODUCT. RESULT THE SOFT COMPONENT OF THE UP AND DOWN BUTTON IS DAMAGED DUE TO HANDLING WITH SHARP OBJECTS. THE BUTTONS SHOULDN'T BE ACTUATED BY USING HARD OR SHARP OBJECTS. DUE TO THE LEAKY SOFT COMPONENTS LIQUID ENTERED THE PUMP ELECTRONICS. THE RESULTING SHORT CIRCUIT DAMAGED THE PUMP ELECTRONICS AND LED TO THE E8 ERROR MESSAGE(S). DUE TO THE LEAKY SOFT COMPONENTS LIQUID ENTERED AND ALWAYS ACTIVE BUTTON (S) IS THE RESULTING. AN ALWAYS ACTIVE BUTTON BLOCKED ALL OTHER BUTTONS. THE PROBLEM MENTIONED BY THE CUSTOMER IS RELATED TO MISHANDLING OF THE PRODUCT BY THE CUSTOMER.

    Additional Manufacturer Narrative · 1

    THIS INCIDENT OCCURRED OUTSIDE THE UNITED STATES. INFORMATION CONTAINED WITHIN THIS REPORT IS ALL THAT IS AVAILABLE AT THIS TIME. IF FURTHER INFORMATION IS OBTAINED IT WILL BE PROVIDED IN A SUPPLEMENTAL REPORT.

    Description of Event or Problem · 1

    PATIENT REPORTED THE INFUSION DEVICE IS NOT WORKING. PATIENT STATED SHE IS CURRENTLY OUT OF THE COUNTRY AND WILL NOT BE BACK UNTIL NEXT YEAR. PATIENT REPORTED THE INFUSION DEVICE IS NOT COMING ON AND IT LOOKS LIKE THERE IS MOISTURE IN THE DISPLAY. PATIENT STATED THERE IS NO RESPONSE WHEN PRESSING ANY BUTTONS. PATIENT REPORTED THE DEVICE WAS WORKING 2 HOURS AGO. PATIENT STATED THE INFUSION DEVICE VIBRATED WITHOUT HER PRESSING ANY BUTTONS AND THE DISPLAY SHOWED A STANDARD BOLUS OF 0.0, AS IF SHE HAD PRESSED THE QUICK BOLUS, AND AFTER THAT WOULD NOT DO ANYTHING. PATIENT REPORTED IS HAS BEEN HOT BUT NOT HUMID. ADVISED TO REMOVE THE BATTERY; PATIENT STATED SHE THINKS IT WAS INSERTED ABOUT 3 WEEKS AGO. HAD PATIENT REINSERT THE BATTERY AND THE INFUSION DEVICE GOES THROUGH SELF-TEST AND THEN SHOWS E8 (POWER INTERRUPT) ERROR MESSAGE; IS UNABLE TO CLEAR THIS BECAUSE THE CHECK BUTTON IS NOT RESPONDING. ADVISED PATIENT TO LET INFUSION DEVICE SIT IN A COOL, DRY AREA FOR A FEW HOURS AND THEN INSERT A NEW BATTERY TO SEE IF THE DISPLAY WILL DRY OUT AND IF THE DEVICE WILL TURN ON CORRECTLY AND ALSO IF THE BUTTONS WILL WORK. NO FURTHER INFORMATION IS AVAILABLE. NO PHYSIOLOGICAL EFFECTS WERE REPORTED. THE PATIENT DID NOT REQUIRE ASSISTANCE FROM A HEALTHCARE PROFESSIONAL OR SECOND PART

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    344289 ACCU-CHEK SPIRIT COMBO INSULIN INFUSION PUMP LZG ROCHE HEALTH SOLUTIONS, INC 00700006863 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 026 YR