BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACCU-CHEK ® SPIRIT COMBO

    MDR report key: 3913629 · Received July 3, 2014

    Report

    Report Number
    1823260-2014-04902
    Event Type
    Malfunction
    Date Received
    July 3, 2014
    Date of Event
    May 15, 2014
    Report Date
    August 20, 2014
    Manufacturer
    ROCHE DIAGNOSTICS
    Product Code
    LZG
    PMA / PMN Number
    NA
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE

    Narratives

    Additional Manufacturer Narrative · 1

    THE EVENT OCCURRED IN (B)(6).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE INFUSION DEVICE DID NOT DISPLAY E4 (OCCLUSION ERROR) DURING THE PAST 3-4 WEEKS WHEN THE PATIENT THOUGHT IT SHOULD HAVE. THE PATIENT EXPERIENCED ELEVATED BLOOD GLUCOSE LEVELS AS HIGH AS 400 MG/DL. NO ADVERSE EVENT WAS REPORTED. THE INFUSION DEVICE WAS REQUESTED TO BE RETURNED FOR PRODUCT EVALUATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    391296 ACCU-CHEK ® SPIRIT COMBO INSULIN INFUSION PUMP LZG ROCHE DIAGNOSTICS NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1 012 YR