BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACCU-CHEK SPIRIT COMBO

    MDR report key: 3100597 · Received May 8, 2013

    Report

    Report Number
    2183996-2013-00811
    Event Type
    Malfunction
    Date Received
    May 8, 2013
    Date of Event
    May 2, 2013
    Report Date
    July 31, 2013
    Manufacturer
    ROCHE DIABETES CARE AG
    Product Code
    LZG
    PMA / PMN Number
    NA
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE

    Narratives

    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.

    Additional Manufacturer Narrative · 1

    CONCLUSION: THE COMPLAINT CANNOT BE VERIFIED, THE PRODUCT MEETS THE SPECIFICATION REGARDING THE CUSTOMER'S ALLEGATION. 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: ACCORDING TO THE PUMP HISTORY THE TIME/DATE SETTINGS HAVE BEEN LOST AFTER RESTART OF THE PUMP/BATTERY CHANGE. THE ACID OF THE SUPERCAP HAS LEAKED OUT. THEREFORE, THE SUPERCAP AND THE SURROUNDING ELECTRONIC PARTS ARE CORRODED. THE SUPERCAP WAS NOT FUNCTIONING ANYMORE AND DID NOT PROVIDE ENERGY DURING THE BATTERY CHANGE TO KEEP THE DATE/TIME SETTING IN MEMORY. A SUPERCAP IS A CAPACITOR USED FOR PROVIDING ENERGY TO THE MEMORY INTEGRATED CIRCUIT TO KEEP THE DATE AND TIME SETTING FOR A WHILE, WHEN NO BATTERY IS IN THE PUMP. THE INSULIN PUMP CORRECTLY NOTIFIED THE USER TO CHECK THE DATE AND TIME SETTING AFTER RESTART. THE HISTORY ANALYSIS SHOWED, THAT THE USER DID NOT SET THE DATE AND TIME CORRECTLY WHEN THE INSULIN PUMP RESTARTED. THEREFORE, THE HOURLY BASAL RATE SETTINGS DIFFERED FROM THE RATES NORMALLY APPLIED, WHEN THE PUMP HAS THE DATE/TIME PROPERLY ADJUSTED. THE CUSTOMER'S ALLEGATION THAT THE PUMP SET THE WRONG DATE/TIME COULD NOT BE REPRODUCED. HISTORY LIST: (B)(6) 2013, AFTER A BATTERY CHANGE AT 13:45, THE CUSTOMER SET THE WRONG DATE/TIME. THE CUSTOMER SET THE TIME TO 01.49 AM INSTEAD 13:49 PM. AFTER THIS WRONG DATE/TIME CHANGE, THE BASAL DELIVERY IS NOT CORRECTLY ADJUSTED FOR THE CUSTOMER'S INSULIN THERAPY. ON (B)(6) 2013, THE CUSTOMER CHANGED THE WRONG TIME SETTING FROM 06.34 AM TO 18:37 PM. THE PROBLEM MENTIONED BY THE CUSTOMER COULD NOT BE REPRODUCED.

    Description of Event or Problem · 1

    PATIENT REPORTED EXPERIENCING ELEVATED BLOOD GLUCOSE LEVELS OF 200-210 MG/DL ON (B)(6) 2013; TOOK CORRECTION WITH THE INFUSION DEVICE AND WAS SUCCESSFUL. PATIENT STATED AT 6 PM HE NOTICED THAT THE INFUSION DEVICE HAS CHANGED THE TIME. PATIENT REPORTED THE TIME ON THE INFUSION DEVICE WAS 6 AM AND THE BASAL RATE DISPLAYED WAS FROM 6 AM. PATIENT STATED THE LAST BATTERY CHANGE WAS ON (B)(6) 2013. PATIENT STATED AFTER NOTICING THE ISSUE HE CORRECTED THE TIME AND DATE. NO FURTHER INFORMATION IS AVAILABLE. THE PATIENT DID NOT REQUIRE ASSISTANCE FROM A HEALTHCARE PROFESSIONAL OR SECOND PARTY TO ADDRESS THE ISSUE. REQUESTED RETURN OF THE ALLEGED INFUSION DEVICE FOR EVALUATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    201474 ACCU-CHEK SPIRIT COMBO INSULIN INFUSION PUMP LZG ROCHE DIABETES CARE AG 00700006863 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 072 YR