BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACCU-CHEK SPIRIT COMBO

    MDR report key: 3011846 · Received March 19, 2013

    Report

    Report Number
    2183996-2013-00414
    Event Type
    Malfunction
    Date Received
    March 19, 2013
    Date of Event
    August 25, 2012
    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

    THE COMPLAINT CANNOT BE VERIFIED. THE PRODUCT MEETS THE SPECIFICATIONS REGARDING THE CUSTOMER'S ALLEGATION. 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. E4 OCCLUSION ERRORS WERE FOUND IN THE HISTORY, AND THE OCCLUSION LIMITS WERE TESTED SUCCESSFULLY.

    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) 2012, IT WAS REPORTED THAT THE PATIENT'S BLOOD GLUCOSE LEVEL WAS OFTEN ELEVATED BETWEEN 250-330 MG/DL SINCE (B)(6) 2012 AND HER INFUSION DEVICE HAS OFTEN DISPLAYED E4 (OCCLUSION ERROR) DURING THE PAST EIGHT WEEKS. DURING THE PAST THREE WEEKS SHE HAS FELT SICK, HAD HEADACHE, NAUSEA, AND VOMITING. ON (B)(6) 2013, HER BLOOD GLUCOSE WAS ELEVATED AND SHE WAS NOT SUCCESSFUL CORRECTING IT WITH THE INFUSION DEVICE. THE PATIENT SWITCHED TO HER BACKUP DEVICE AND HER BLOOD GLUCOSE LEVELS RETURNED TO NORMAL. THE PATIENT THINKS HER PRIMARY INFUSION DEVICE DOES NOT DELIVER ENOUGH 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
    114559 ACCU-CHEK SPIRIT COMBO INSULIN INFUSION DEVICE LZG ROCHE DIABETES CARE AG 00700006863 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 047 YR