BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACCU-CHEK ® SPIRIT COMBO

    MDR report key: 3944922 · Received July 18, 2014

    Report

    Report Number
    1823260-2014-05375
    Event Type
    Malfunction
    Date Received
    July 18, 2014
    Date of Event
    June 6, 2014
    Report Date
    August 6, 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

    THE PATIENT EXPERIENCED ELEVATED BLOOD GLUCOSE LEVELS AS HIGH AS 430 MG/DL FOR THE PAST THREE WEEKS. THE PATIENT WAS UNSUCCESSFUL AT LOWERING THE ELEVATED LEVELS VIA THE INFUSION DEVICE EVEN AFTER CHANGING THE DEVICE'S ACCESSORIES. 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
    421970 ACCU-CHEK ® SPIRIT COMBO INSULIN INFUSION PUMP LZG ROCHE DIAGNOSTICS NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1 074 YR