BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACCU-CHEK ® SPIRIT COMBO

    MDR report key: 3930114 · Received July 11, 2014

    Report

    Report Number
    1823260-2014-05138
    Event Type
    Malfunction
    Date Received
    July 11, 2014
    Date of Event
    June 15, 2014
    Report Date
    August 4, 2014
    Manufacturer
    ROCHE DIAGNOSTICS
    Product Code
    LZG
    PMA / PMN Number
    NA
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SW
    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 PUMP WARNS FREQUENTLY FOR OCCLUSION. CALLER STATED THE PATIENT CAN JUST START IT AGAIN AFTER THE WARNING, WITHOUT CHANGING ANYTHING AND THE PUMP WORKS AGAIN. CALLER REPORTED THERE ARE OTHER TIMES, IN SPITE OF REPLACING THE COMPLETE INFUSION SET, THE PUMP WARNS RIGHT AWAY AGAIN. CALLER STATED THE DAY BEFORE YESTERDAY AND YESTERDAY THE PATIENT EXPERIENCED ELEVATED BLOOD GLUCOSE READINGS. CALLER SUSPECTS PATIENT HAS NOT GOTTEN ENOUGH INSULIN AS HER READINGS ARE SO HIGH; EXACT READING WAS NOT PROVIDED. CALLER REPORTED PATIENT HAS SWITCHED TO INJECTION THERAPY. CALLER ALLEGES INACCURATE DELIVERY OF INSULIN. NO ADVERSE EVENT REPORTED. REQUESTED RETURN OF THE ALLEGED PUMP FOR EVALUATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    407968 ACCU-CHEK ® SPIRIT COMBO INSULIN INFUSION PUMP LZG ROCHE DIAGNOSTICS NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1 023 YR