BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACCU-CHEK SPIRIT COMBO

    MDR report key: 2932169 · Received January 18, 2013

    Report

    Report Number
    2183996-2013-00052
    Event Type
    Malfunction
    Date Received
    January 18, 2013
    Date of Event
    December 8, 2012
    Report Date
    March 11, 2013
    Manufacturer
    ROCHE HEALTH SOLUTIONS, INC.
    Product Code
    LZG
    PMA / PMN Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    THE INFUSION DEVICE WAS THOROUGHLY EVALUATED AND MEETS SPECIFICATIONS. THE DEVICE DELIVERS THE PROGRAMMED AMOUNT OF INSULIN CORRECTLY AND FUNCTIONS AS INTENDED. THE ISSUE REPORTED BY THE PATIENT COULD NOT BE DUPLICATED.

    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

    ON (B)(6) 2013, IT WAS REPORTED THAT THE PT DOES NOT THINK HIS INFUSION DEVICE IS DELIVERING THE BASAL RATES. HE STATED THAT THE BASAL RATES HAVE NOT BEEN CORRECTLY DELIVERED FOR 4-5 WEEKS AND HIS BLOOD GLUCOSE LEVELS HAVE BEEN OVER 300 MG/DL. THE PT HAS BEEN ABLE TO CORRECT THE ELEVATED BLOOD GLUCOSE LEVELS VIA THE INFUSION DEVICE. THE PT 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 EVAL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    28483 ACCU-CHEK SPIRIT COMBO LZG ROCHE HEALTH SOLUTIONS, INC. 00700006863 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 55 YR RELATED ACCESSORIES| INSULIN INFUSION PUMP| INSULIN