BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACCU-CHEK SPIRIT COMBO

    MDR report key: 2253769 · Received August 10, 2011

    Report

    Report Number
    2183996-2011-02209
    Event Type
    Malfunction
    Date Received
    August 10, 2011
    Date of Event
    July 30, 2011
    Report Date
    August 4, 2011
    Manufacturer
    ROCHE INSULIN DELIVERY SYSTEMS INC
    Product Code
    LZG
    PMA / PMN Number
    NA
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IT
    Reporter Occupation
    UNKNOWN

    Narratives

    Additional Manufacturer Narrative · 1

    THIS INCIDENT OCCURRED OUTSIDE THE UNITED STATES. INFO CONTAINED WITHIN THIS REPORT IS ALL THAT IS AVAILABLE AT THIS TIME. IF FURTHER INFO IS OBTAINED IT WILL BE PROVIDED IN THE SUPPLEMENTAL REPORT.

    Description of Event or Problem · 1

    PT REPORTED NOTICING AN INCREASE IN BLOOD GLUCOSE LEVELS THAT REACHED 480 MG/DL DURING THE LAST WEEK. PT STATED HE ATTEMPTED TO LOWER THE BLOOD GLUCOSE LEVEL BY BOLUSING BUT THE PROBLEM PERSISTED. PT REPORTED HE NOTICED THERE WAS A SMALL BUMP ON THE SKIN UNDER THE NEEDLE WHICH COULD HAVE CAUSED AN INACCURATE DELIVERY. PT STATED DURING THAT TIME THE INFUSION DEVICE DIDN'T GIVE ANY ERROR/ALERT MESSAGES. NO FURTHER INFO IS AVAILABLE. NO PHYSIOLOGICAL EFFECTS WERE REPORTED. THE PT DID NOT REQUIRE ASSISTANCE FROM A HEALTHCARE PROFESSIONAL OR SECOND PARTY TO ADDRESS THE ISSUE. PRODUCT WAS REPLACED AND REQUESTED RETURN OF THE ALLEGED PRODUCT FOR EVAL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ACCU-CHEK SPIRIT COMBO INSULIN INFUSION PUMP LZG ROCHE INSULIN DELIVERY SYSTEMS INC NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1 INSULIN INFUSION SET| INSULIN