BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACCU-CHEK ® SPIRIT COMBO

    MDR report key: 3143416 · Received June 3, 2013

    Report

    Report Number
    2183996-2013-01001
    Event Type
    Malfunction
    Date Received
    June 3, 2013
    Date of Event
    May 31, 2013
    Report Date
    July 11, 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
    NL
    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 THE PROBLEM MENTIONED BY THE CUSTOMER COULD NOT BE REPRODUCED. IN THE PUMP HISTORY DOES NOT EXIST A W2 OR E2 BECAUSE THE USER ALWAYS CHANGES THE BATTERY BEFORE THE VOLTAGES LEVEL IS REACHED TO GIVE A W2 OR E2. THE PROBLEM MENTIONED BY THE CUSTOMER COULD NOT BE REPRODUCED.

    Description of Event or Problem · 1

    PATIENT REPORTED THE INFUSION DEVICE DOES NOT GIVE A W2 (BATTERY LOW) WARNING SIGNAL, IT ONLY GIVES THE E2 (BATTERY DEPLETED) ERROR MESSAGE. PATIENT STATED THERE ARE NO W2 WARNING SIGNALS IN THE HISTORY OF THE INFUSION DEVICE. NO FURTHER INFORMATION IS AVAILABLE. NO PHYSIOLOGICAL EFFECTS WERE REPORTED. 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
    245346 ACCU-CHEK ® SPIRIT COMBO INSULIN INFUSION PUMP LZG ROCHE DIABETES CARE AG 00700006863 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 072 YR