BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACCU-CHEK ® SPIRIT COMBO

    MDR report key: 3921500 · Received July 9, 2014

    Report

    Report Number
    1823260-2014-05004
    Event Type
    Malfunction
    Date Received
    July 9, 2014
    Date of Event
    June 16, 2014
    Report Date
    July 23, 2014
    Manufacturer
    ROCHE DIAGNOSTICS
    Product Code
    NBW
    PMA / PMN Number
    NA
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FI
    Reporter Occupation
    MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE

    Narratives

    Additional Manufacturer Narrative · 1

    THE EVENT OCCURRED IN (B)(6).

    Description of Event or Problem · 1

    CALLER REPORTED THE BUTTONS OF THE PUMP ARE WORKING INTERMITTENTLY. CALLER STATED THERE ARE TIMES WHEN THE BUTTONS ARE NOT RESPONDING AT ALL AND THEN AGAIN THE BUTTONS WILL WORK AFTER PRESSING THEM SEVERAL TIMES. NO ADVERSE EVENT REPORTED. REQUESTED RETURN OF THE ALLEGED PUMP FOR EVALUATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    401706 ACCU-CHEK ® SPIRIT COMBO INSULIN INFUSION PUMP NBW ROCHE DIAGNOSTICS NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1