BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACCU-CHEK ® SPIRIT COMBO

    MDR report key: 3950461 · Received July 22, 2014

    Report

    Report Number
    1823260-2014-05424
    Event Type
    Malfunction
    Date Received
    July 22, 2014
    Date of Event
    June 25, 2014
    Report Date
    September 8, 2014
    Manufacturer
    ROCHE DIAGNOSTICS
    Product Code
    LZG
    PMA / PMN Number
    NA
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE

    Narratives

    Additional Manufacturer Narrative · 1

    THE EVENT OCCURRED IN (B)(6).

    Description of Event or Problem · 1

    PATIENT REPORTED THE PUMP STOPPED WORKING DURING USE. PATIENT STATED HE FELT HIS BLOOD GLUCOSE LEVEL WAS GOING HIGH ABOUT AN HOUR AGO; DOES NOT HAVE METER WITH HIM. PATIENT REPORTED HE ESTIMATES HIS BLOOD GLUCOSE LEVEL TO BE IN THE 20'S MMOL/L BASED ON THE WAY HE FEELS. PATIENT STATED HIS LAST READING WAS 9.2 MMOL/L AT 4 AM. PATIENT REPORTED HE NOTICED HIS PUMP WAS NOT ON AND DID NOT RESPOND TO ANY BUTTON PRESSES. PATIENT STATED HE CHANGED TO A NEW BATTERY BUT THE PUMP DID NOT POWER ON. NO ADVERSE EVENT REPORTED. REQUESTED RETURN OF THE ALLEGED PUMP FOR EVALUATION

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    428285 ACCU-CHEK ® SPIRIT COMBO INSULIN INFUSION PUMP LZG ROCHE DIAGNOSTICS NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1 033 YR