BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACCU-CHEK ® SPIRIT COMBO

    MDR report key: 3896545 · Received June 26, 2014

    Report

    Report Number
    1823260-2014-04706
    Event Type
    Malfunction
    Date Received
    June 26, 2014
    Date of Event
    May 21, 2014
    Report Date
    July 21, 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

    REPORTER STATED THE INFUSION DEVICE HAS SHUT-DOWN WITHOUT PROVIDING AN ERROR MESSAGE, AND THE CUSTOMER HAS EXPERIENCED HYPERGLYCEMIA OF UP TO 500 MG/DL AS A RESULT. NO ADVERSE EVENT WAS REPORTED. THE ALLEGED PRODUCT WAS REQUESTED FOR EVALUATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    374717 ACCU-CHEK ® SPIRIT COMBO INSULIN INFUSION PUMP LZG ROCHE DIAGNOSTICS NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1 018 YR