BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACCU-CHEK SPIRIT COMBO

    MDR report key: 3052162 · Received April 11, 2013

    Report

    Report Number
    2183996-2013-00649
    Event Type
    Malfunction
    Date Received
    April 11, 2013
    Date of Event
    April 2, 2013
    Report Date
    May 22, 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 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 THE PATIENT HAD EXPERIENCED ELEVATED BLOOD GLUCOSE LEVELS AS HIGH AS 366 MG/DL FOR ONE WEEK. THE PATIENT HAD BEEN UNSUCCESSFUL CORRECTING THE HYPERGLYCEMIA EVEN AFTER CHANGING THE INFUSION SET, BUT SHE WAS SUCCESSFUL CORRECTING THE ELEVATED BLOOD GLUCOSE LEVELS VIA INSULIN INJECTION. THE PATIENT THINKS THE DEVICE DELIVERS TOO LOW AN AMOUNT OF INSULIN. HER DIABETIC SPECIALIST CHECKED THE BASAL RATES AND THEY WERE SET CORRECTLY. 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
    155204 ACCU-CHEK SPIRIT COMBO INSULIN INFUSION DEVICE LZG ROCHE DIABETES CARE AG 00700006863 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 064 YR