BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACCU-CHEK ® SPIRIT COMBO

    MDR report key: 3930099 · Received July 11, 2014

    Report

    Report Number
    1823260-2014-05135
    Event Type
    Malfunction
    Date Received
    July 11, 2014
    Date of Event
    June 18, 2014
    Report Date
    July 29, 2014
    Manufacturer
    ROCHE DIAGNOSTICS
    Product Code
    LZG
    PMA / PMN Number
    NA
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IT
    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'S MOTHER REPORTED WHILE REPLACING THE CARTRIDGE THE PISTON BEGAN TO MAKE A STRANGE NOISE AND HAD DIFFICULTY REWINDING. MOTHER STATED THE PUMP DISPLAYS AN E10 (CARTRIDGE ERROR) MESSAGE. MOTHER STATED YESTERDAY IN THE AFTERNOON, SHE PERFORMED A CARTRIDGE CHANGE AND THE PATIENT'S BLOOD GLUCOSE LEVEL WAS 176 MG/DL AND THEN BEFORE DINNER IT WAS 259 MG/DL. MOTHER REPORTED IN THE PREVIOUS DAYS THAT WHILE STILL USING THE SAME BASAL RATE DURING MEALTIMES, THE BLOOD GLUCOSE LEVEL WAS LOWER AT 84 MG/DL. MOTHER STATED SHE TRIED TO MAKE A FAKE BOLUS AND NOTICED THE PUMP DIDN'T DELIVER ALL OF THE INSULIN; IT HAD DIFFICULTIES IN BEING DELIVERED AND NOW THE PISTON IS BLOCKED AND THE PUMP DOESN'T WORK. NO ADVERSE EVENT REPORTED. REQUESTED RETURN OF THE ALLEGED PUMP FOR EVALUATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    407229 ACCU-CHEK ® SPIRIT COMBO INSULIN INFUSION PUMP LZG ROCHE DIAGNOSTICS NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1