BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACCU-CHEK SPIRIT COMBO

    MDR report key: 3103254 · Received May 9, 2013

    Report

    Report Number
    2183996-2013-00828
    Event Type
    Malfunction
    Date Received
    May 9, 2013
    Date of Event
    April 29, 2013
    Report Date
    September 11, 2013
    Manufacturer
    ROCHE DIABETES CARE AG
    Product Code
    LZG
    PMA / PMN Number
    K111353
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    PATIENT

    Narratives

    Additional Manufacturer Narrative · 1

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

    Additional Manufacturer Narrative · 1

    CONCLUSION: THE COMPLAINT CANNOT BE VERIFIED, THE PRODUCT MEETS THE SPECIFICATION REGARDING THE CUSTOMER'S ALLEGATION. RESULT: NO W4 AND W9 IN THE PUMP HISTORY. E4 WERE FOUND IN THE HISTORY. THE OCCLUSION LIMITS WERE TESTED SUCCESSFULLY. W8 IS A CONSEQUENCE WARNING OF THE E4. CONSUMABLES THE ADAPTER AND THE BATTERY COVER PASSED THE OPTICAL INSPECTION. THE PROBLEM MENTIONED BY THE CUSTOMER COULD NOT BE REPRODUCED.

    Additional Manufacturer Narrative · 1

    CONCLUSION: THE COMPLAINT CANNOT BE VERIFIED, THE PRODUCTION DATA SHOWS NO DEVIATIONS OF THE SPECIFICATIONS RESULT AS THE PRODUCT HAS NOT BEEN RETURNED FOR INVESTIGATION AND THE PRODUCTION DATA COMPLY WITH THE SPECIFICATION, THE COMPLAINT COULD NOT BE REPLICATED. PRODUCTION REPORTS WERE REVIEWED. AS THE PRODUCT HAS NOT RETURNED FOR EVALUATION, THE COMPLAINT COULD NOT BE INVESTIGATED.

    Description of Event or Problem · 1

    ON (B)(6) 2013 PATIENT REPORTED THE INFUSION DEVICE DISPLAYED W4, W8, W9 AND OCCLUSION ALARMS. PATIENT STATED SHE CHANGED INFUSION SET, TUBING AND CARTRIDGE SEVEN TIMES TODAY BUT THE OCCLUSIONS PERSIST. HAD PATIENT CHECK MEMORY OF INFUSION DEVICE; FOUND W4 (LIFETIME WARNING), W9 (LOANTIME WARNING), W8 (BOLUS CANCELLED) AND SEVERAL E4 (OCCLUSION) ERROR MESSAGE IN THE MEMORY OF THE INFUSION DEVICE. ADVISED PATIENT THAT W4 AND W9 ARE ASSOCIATED WITH THE INFUSION DEVICE TIMER ALARMS. THE INFUSION DEVICE'S MEMORY DID NOT HAVE A PUMP TIMER SECTION UNDER MY DATA. PATIENT REPORTED THE INFUSION SETS HAD BEEN IN USE LESS THAN 24 HOURS WHEN THE OCCLUSIONS BEGAN. PATIENT STATED THE ADAPTER AND BATTERY COVER HAD BEEN IN SINCE (B)(6) 2013. ADVISED TO CHANGE THE BATTERY COVER AND ADAPTER EVERY 2 MONTHS. ADVISED TO CHANGE INFUSION SET EVERY 2 DAYS. HAD PATIENT TO DISCONNECT THE TUBING FROM THE INFUSION SET AND PRIME UNTIL INSULIN DRIPPED FROM THE END OF THE TUBING AND THEN ATTACH A NEW CANNULA TO THE TUBING AND PRIME THROUGH. PATIENT REPORTED SHE WAS ABLE TO ATTACH THE NEW INFUSION SET AND PLACE THE INFUSION DEVICE INTO RUN MODE; DID NOT DELIVER A BOLUS AT THIS TIME. ON CALLBACK ON (B)(6) 2013 PATIENT REPORTED SHE IS STILL RECEIVING ERROR ALERTS ON THE INFUSION DEVICE EVERY 2 HOURS. PATIENT REPORTED ERROR CODES THAT ARE NOT MATCHING WITH THE CONCERN. PATIENT STATED SHE SPOKE TO THE ACCOUNT MANAGER AND WAS INSTRUCTED TO CALL AND HAVE THE INFUSION DEVICE REPLACED. ON CALL BACK PATIENT REPORTED SHE BEGAN USING THE INFUSION DEVICE ON (B)(6) 2013. ON CALL BACK ON (B)(6) 2013 PATIENT REPORTED SHE DID RECEIVE THE NEW INFUSION DEVICE. PATIENT STATED SHE DISCARDED THE INFUSION SET AND IS NOT ABLE TO SEND IT BACK FOR INVESTIGATION. NO PHYSIOLOGICAL EFFECTS WERE REPORTED. 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 FOR EVALUATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    202873 ACCU-CHEK SPIRIT COMBO INSULIN INFUSION PUMP LZG ROCHE DIABETES CARE AG NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1 037 YR LIPITOR| COVERSIL| NOVORAPID U100 INSULIN