BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACCU-CHEK SPIRIT COMBO

    MDR report key: 3221246 · Received July 11, 2013

    Report

    Report Number
    2183996-2013-01269
    Event Type
    Malfunction
    Date Received
    July 11, 2013
    Date of Event
    July 1, 2013
    Report Date
    August 13, 2013
    Manufacturer
    ROCHE HEALTH SOLUTIONS INC
    Product Code
    LZG
    PMA / PMN Number
    NA
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AU
    Reporter Occupation
    MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE

    Narratives

    Additional Manufacturer Narrative · 1

    THE 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 THE SUPPLEMENTAL REPORT.

    Additional Manufacturer Narrative · 1

    THE SOFT COMPONENT OF THE UP AND DOWN BUTTON IS DAMAGED DUE TO HANDLING WITH SHARP OBJECTS. DUE TO THE SEVERE DAMAGES ON THE SOFT COMPONENT, LIQUID ENTERED THE PUMP ELECTRONICS COMPARTMENT AND LED TO A CORRODED ELECTRICAL CONNECTOR OF THE BUTTONS AND THE SUPERCAP. THEREFORE THE INSULIN PUMPS UP- RESPECTIVELY DOWN-BUTTON IS DEFECTIVE. A SHORTCUT ON THE SUPERCAP LED TO CONSTANTLY REBOOT OF THE INSULIN PUMP. A SUPERCAP IS A CAPACITOR FOR SAVING THE DATE AND TIME FOR A WHILE, WHEN NO BATTERY IS IN THE PUMP. THE PROBLEM MENTIONED BY THE CUSTOMER IS RELATED TO A HANDLING .

    Description of Event or Problem · 1

    ON (B)(6) 2013, IT WAS REPORTED THAT THE PATIENT'S INFUSION DEVICE DISPLAYED A2 (BATTERY LOW). SHE CHANGED THE BATTERY IN THE DEVICE AND THEN NONE OF THE BUTTONS ON THE DEVICE WOULD FUNCTION. SHE CHANGED THE BATTERY A SECOND TIME, BUT THE BUTTONS STILL WOULD NOT FUNCTION. THE PATIENT STATED THAT THE RUBBER COVERING OF THE UP BUTTON WAS TORN. SHE STATED THAT SHE HAD NOTICED DAMPNESS UNDER THE DISPLAY OF THE DEVICE. ALSO THE DEVICE DID NOT KEEP THE DATE AND TIME SETTINGS. NO PHYSIOLOGICAL EFFECTS WERE REPORTED. THE PATIENT DID NOT REQUIRE MEDICAL ASSISTANCE FROM A HEALTHCARE PROFESSIONAL OR SECOND PARTY TO ADDRESS THE ISSUE. THE INFUSION DEVICE WAS REQUESTED TO BE RETURNED FOR PRODUCT EVALUATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    320146 ACCU-CHEK SPIRIT COMBO INSULIN INFUSION PUMP LZG ROCHE HEALTH SOLUTIONS INC 00700006863 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 048 YR