BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACCU-CHEK SPIRIT COMBO

    MDR report key: 1945894 · Received December 28, 2010

    Report

    Report Number
    2183996-2010-02698
    Event Type
    Malfunction
    Date Received
    December 28, 2010
    Date of Event
    December 8, 2010
    Report Date
    December 21, 2010
    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
    GM
    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, THE INFUSION DEVICE DOES NOT DISPLAY A W2 (BATTERY LOW) ALERT. PT STATED, HE CHANGED THE INFUSION CARTRIDGE AND PRIMED THE INFUSION SET. PT REPORTED, THE INFUSION DEVICE SWITCHED OFF WITHOUT AN ALARM OR ERROR MESSAGE. PT STATED, HIS BLOOD GLUCOSE LEVEL IS OKAY. PT IS UNSURE OF THE EXACT DATE OF THE INCIDENT; PROBABLY (B)(6) 2010 OR (B)(6) 2010. 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 38 YR INSULIN| INSULIN INFUSION SET