BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACCU-CHEK ® SPIRIT COMBO

    MDR report key: 3122767 · Received May 21, 2013

    Report

    Report Number
    2183996-2013-00901
    Event Type
    Malfunction
    Date Received
    May 21, 2013
    Date of Event
    May 14, 2013
    Report Date
    July 29, 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 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 FOLLOWING E8 ERROR MESSAGE(S): E8 WERE FOUND IN THE HISTORY. THE UP AND DOWN BUTTON IS ALWAYS ACTIVE. DUE TO AN EXTERNAL MECHANICAL INFLUENCE THE SNAP DOME OF THE BUTTONS IS PRESSED THROUGH. THIS SOURCE LED TO AN ALWAYS ACTIVATED UP AND DOWN BUTTON AND UNCLEAR ABLE E8 ERROR MESSAGES. THE PROBLEM MENTIONED BY THE CUSTOMER IS RELATED TO MISHANDLING OF THE PRODUCT BY THE CUSTOMER.

    Description of Event or Problem · 1

    PATIENT REPORTED THAT ON (B)(6) 2013, THE INFUSION DEVICE WAS OFF AND NOT RESPONDING. PATIENT STATED THE INFUSION DEVICE DID NOT DISPLAY AN ALARM OR ERROR MESSAGE. PATIENT REPORTED THE BLOOD GLUCOSE LEVEL IS OKAY; NO EXACT READING WAS PROVIDED. PATIENT'S NORMAL BLOOD GLUCOSE RANGE WAS NOT PROVIDED. 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
    224885 ACCU-CHEK ® SPIRIT COMBO INSULIN INFUSION PUMP LZG ROCHE DIABETES CARE AG 00700006863 NA

    Patients

    Seq Age Sex Outcome Treatment
    1