BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACCU-CHEK SPIRIT COMBO

    MDR report key: 3012098 · Received March 20, 2013

    Report

    Report Number
    2183996-2013-00445
    Event Type
    Malfunction
    Date Received
    March 20, 2013
    Date of Event
    February 13, 2013
    Report Date
    May 10, 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
    IT
    Reporter Occupation
    MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE

    Narratives

    Additional Manufacturer Narrative · 1

    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 DURING THE PAST MONTH THE PATIENT'S BLOOD GLUCOSE LEVEL HAD BEEN ELEVATED FROM 300-450 MG/DL IN THE MORNING ON 4-5 OCCASIONS. THE PATIENT STATED THAT THE DEVICE NEVER DISPLAYED ANY ERROR OR ALERT MESSAGES. HE ALSO STATED THAT THE PISTON ROD OF THE INFUSION DEVICE GOES INTO THE INSULIN CARTRIDGE AND CONTINUES TO MOVE. ON (B)(6) 2013, THE PATIENT SWITCHED TO AN OLDER INFUSION DEVICE AND HIS BLOOD GLUCOSE LEVEL RETURNED TO NORMAL. THE PATIENT THINKS THE ELEVATED BLOOD GLUCOSE LEVELS ARE DUE TO THE INFUSION DEVICE DELIVERING TOO LOW AN AMOUNT OF INSULIN. THE PATIENT DID NOT REQUIRE MEDICAL ASSISTANCE FROM A HEALTHCARE PROFESSIONAL OR SECOND PARTY TO ADDRESS THE ISSUE. INFUSION DEVICE WAS REQUESTED TO BE RETURNED FOR PRODUCT EVALUATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    115493 ACCU-CHEK SPIRIT COMBO INSULIN INFUSION DEVICE LZG ROCHE DIABETES CARE AG 00700006863 NA

    Patients

    Seq Age Sex Outcome Treatment
    1