BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACCU-CHEK ® SPIRIT COMBO

    MDR report key: 4131584 · Received October 1, 2014

    Report

    Report Number
    1823260-2014-07479
    Event Type
    Malfunction
    Date Received
    October 1, 2014
    Date of Event
    August 18, 2014
    Report Date
    March 12, 2015
    Manufacturer
    ROCHE DIAGNOSTICS
    Product Code
    LZG
    PMA / PMN Number
    K111353
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    PATIENT

    Narratives

    Additional Manufacturer Narrative · 1

    IT WAS UNKNOWN IF THE INITIAL REPORTER SENT REPORT TO THE FDA.

    Description of Event or Problem · 1

    CUSTOMER IS CALLING BECAUSE HIS BLOOD SUGARS HAVE BEEN HIGH LATELY. HE BELIEVES THAT HIS SPIRIT COMBO INSULIN PUMP IS NOT DELIVERING INSULIN CORRECTLY. CUSTOMER STATED HE HAS BEEN ABLE TO SELF TREAT TO BRING HIS BLOOD SUGAR BACK DOWN. NO ADVERSE EVENT WAS REPORTED. A REQUEST WAS MADE FOR THE RETURN OF THE DEVICE, REPLACEMENT SENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    612274 ACCU-CHEK ® SPIRIT COMBO INSULIN INFUSION PUMP LZG ROCHE DIAGNOSTICS NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1 UNSPECIFIED INSULIN