BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACCU-CHEK SPIRIT COMBO

    MDR report key: 2915367 · Received December 28, 2012

    Report

    Report Number
    2183996-2012-02056
    Event Type
    Malfunction
    Date Received
    December 28, 2012
    Date of Event
    December 17, 2012
    Report Date
    April 16, 2013
    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
    NOT APPLICABLE

    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.

    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.

    Description of Event or Problem · 1

    ON (B)(6) 2012, IT WAS REPORTED THAT THE PT HAD BEEN EXPERIENCING ELEVATED BLOOD GLUCOSE LEVELS. SHE CHANGED ALL THE ACCESSORIES ON THE INFUSION DEVICE, BUT SHE CONTINUED TO HAVE ELEVATED BLOOD GLUCOSE LEVELS. THE PT THINKS THE INFUSION DEVICE DOES NOT DELIVER AN ACCURATE AMOUNT OF INSULIN. THE PT DID NOT REQUIRE MEDICAL ASSISTANCE FROM A HEALTHCARE PROFESSIONAL OR SECOND PARTY TO ADDRESS THE ISSUE. THE INFUSION DEVICE WAS REPLACED AND REQUESTED TO BE RETURNED FOR PRODUCT EVAL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ACCU-CHEK SPIRIT COMBO LZG ROCHE INSULIN DELIVERY SYSTEMS, INC. 00700006863 NA

    Patients

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