BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACCU-CHEK SPIRIT COMBO

    MDR report key: 3012592 · Received March 20, 2013

    Report

    Report Number
    2183996-2013-00451
    Event Type
    Malfunction
    Date Received
    March 20, 2013
    Date of Event
    March 3, 2013
    Report Date
    April 23, 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 CAN NOT BE VERIFIED DUE TO MISHANDLING OF THE PRODUCT. RESULT E8 WERE FOUND IN THE HISTORY. 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). THE PROBLEM MENTIONED BY THE CUSTOMER IS RELATED TO MISHANDLING OF THE PRODUCT BY THE CUSTOMER.

    Description of Event or Problem · 1

    PATIENT REPORTED THE INFUSION DEVICE WENT INTO STOP MODE BY ITSELF AND WITHOUT AN ERROR MESSAGE. PATIENT STATED SHE THEN CHANGED THE BATTERY AND BATTERY COVER AND THE INFUSION DEVICE POWERED ON SHORTLY AND THEN SWITCHED OFF WITHOUT GOING INTO SELF-TEST. PATIENT REPORTED SHE WOKE UP AT 6 AM DUE TO AN ELEVATED BLOOD GLUCOSE LEVEL OF 460 MG/DL. PATIENT'S NORMAL BLOOD GLUCOSE LEVEL WAS NOT PROVIDED. PATIENT STATED SHE WAS ABLE TO GET HER BLOOD GLUCOSE LEVEL UNDER CONTROL BY HERSELF VIA PEN. 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
    116526 ACCU-CHEK SPIRIT COMBO INSULIN INFUSION PUMP LZG ROCHE DIABETES CARE AG 00700006863 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 043 YR