BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACCU-CHEK SPIRIT COMBO

    MDR report key: 3151436 · Received June 7, 2013

    Report

    Report Number
    2183996-2013-01036
    Event Type
    Malfunction
    Date Received
    June 7, 2013
    Date of Event
    September 4, 2012
    Report Date
    July 30, 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

    THE OCCLUSION LIMITS WERE TESTED SUCCESSFULLY. THE DELIVERY ACCURACY OF THE INSULIN PUMP WAS TESTED WITHIN THE PUMP DRIVE TEST ON THE DIAGNOSTIC TEST SYSTEM AND MEETS THE SPECIFICATIONS. THE TECHNICAL INVESTIGATION GAVE NO EVIDENCE THAT THE DEVICE DID CAUSE OR CONTRIBUTE TO THE CONDITION REPORTED BY THE PATIENT.

    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.

    Description of Event or Problem · 1

    ON (B)(6) 2013, IT WAS REPORTED THAT FOR APPROXIMATELY ¾ OF THE YEAR THE PATIENT'S INFUSION DEVICE HAD NOT DISPLAYED E4 (OCCLUSION ERROR). THE PATIENT HAS SEEN BLOOD AND WHITE DEPOSITS IN THE INFUSION TUBING ON OCCASION. THE PATIENT HAS REMOVED THE INFUSION SET FROM HIS BODY AND NO INSULIN CAME OUT OF IT AND THE DEVICE DID NOT DISPLAY AND ERROR MESSAGE. HE EXPERIENCED ELEVATED BLOOD GLUCOSE AS HIGH AS 350 MG/DL. HE ALSO STATED THAT ON (B)(6) 2013, HE NOTICED WETNESS AT THE DEVICE'S ADAPTER AND IN THE CARTRIDGE COMPARTMENT. HE WAS ABLE TO CLEAN THE MOISTURE. 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
    253351 ACCU-CHEK SPIRIT COMBO INSULIN INFUSION DEVICE LZG ROCHE DIABETES CARE AG 00700006863 NA

    Patients

    Seq Age Sex Outcome Treatment
    1