BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DACCU-CHEK SPIRIT COMBO

    MDR report key: 2943255 · Received January 21, 2013

    Report

    Report Number
    2183996-2013-00037
    Event Type
    Malfunction
    Date Received
    January 21, 2013
    Date of Event
    January 7, 2013
    Report Date
    April 3, 2013
    Manufacturer
    ROCHE HEALTH SOLUTIONS, INC.
    Product Code
    LZG
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    THE COMPLAINT CANNOT BE VERIFIED. THE PRODUCT MEETS THE SPECIFICATION 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.

    Additional Manufacturer Narrative · 1

    THIS 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

    PATIENT REPORTED EXPERIENCING AN ELEVATED BLOOD GLUCOSE LEVEL UP TO APPROXIMATELY 400 MG/DL SINCE (B)(6) 2013. PATIENT'S NORMAL BLOOD GLUCOSE LEVEL IS AROUND 100 MG/DL. PATIENT STATED SHE EXPERIENCED HEADACHE AND VISUAL PROBLEMS. PATIENT REPORTED SHE CHANGED THE INFUSION SET CANNULA TWICE, AND TOOK CORRECTION VIA THE INFUSION DEVICE WITH NO SUCCESS. PATIENT STATED ON (B)(6) 2013, SHE TOOK CORRECTION VIA INJECTION WITH NO SUCCESS. PATIENT SWITCHED TO A NEW INFUSION DEVICE AND ON (B)(6) 2013, WITH THE SAME BASAL RATE AND HER BLOOD GLUCOSE LEVEL WAS OKAY. NO FURTHER INFORMATION AVAILABLE. 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
    28860 DACCU-CHEK SPIRIT COMBO LZG ROCHE HEALTH SOLUTIONS, INC. 00700006863 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 053 YR INSULIN INFUSION PUMP| DATE OF THERAPY: UNK| ACCESSORIES| INSULIN