BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ACCU-CHEK ® SPIRIT COMBO

    MDR report key: 3913627 · Received July 3, 2014

    Report

    Report Number
    1823260-2014-04903
    Event Type
    Injury
    Date Received
    July 3, 2014
    Date of Event
    June 9, 2014
    Report Date
    July 3, 2014
    Manufacturer
    ROCHE DIAGNOSTICS
    Product Code
    LZG
    PMA / PMN Number
    NA
    Removal / Correction Number
    NA
    Adverse Event
    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). DEVICE WAS NOT REQUESTED TO BE RETURNED.

    Description of Event or Problem · 1

    NURSE REPORTED PATIENT CAME TO ACCIDENT AND EMERGENCY DEPARTMENT ON (B)(6) 2014 WITH ELEVATED BLOOD GLUCOSE LEVELS AND TRACES OF KETONES; EXACT READING WAS NOT PROVIDED. NURSE STATED PATIENT WAS TREATED WITH INSULIN VIA A DRIP TO REDUCE BLOOD SUGAR LEVELS AND TREATMENT FOR KETONES. NURSE STATED PATIENT WAS ALSO SEEN ON (B)(6) 2014 WITH ELEVATED BLOOD GLUCOSE LEVEL BUT WENT HOME WITH A READING OF 17.9 MMOL/L. NURSE REPORTED PATIENT PERFORMED ANOTHER TEST ONCE SHE GOT HOME WITH A RESULT OF 26 MMOL/L AND TRACES OF KETONES. NURSE STATED PATIENT CONTINUED TO USE THE PUMP TO DELIVER CORRECTION; DID NOT FOLLOW INSTRUCTIONS GIVEN BY ACCIDENT AND EMERGENCY DEPARTMENT. NURSE REPORTED PATIENT BEGAN A TEMPORARY BASAL RATE (TBR) AND WENT TO SLEEP. NURSE STATED PATIENT WOKE UP AT 10 PM AND ATE DINNER; BLOOD GLUCOSE WAS STILL ELEVATED, SO DELIVERED A 10 UNIT BOLUS. NURSE REPORTED PATIENT TESTED AGAIN AT MIDNIGHT AND NOTICED HER CANNULA WAS WET; CHANGED EVERYTHING AND DELIVERED ANOTHER CORRECTION. NURSE STATED SHE HAS DONE A PRIME AND THE PUMP SEEMS FINE; ADVISED TO CHECK HISTORY AND PERFORM A CARTRIDGE CHANGE. NO PRODUCT RETURN WAS REQUESTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    391078 ACCU-CHEK ® SPIRIT COMBO INSULIN INFUSION PUMP LZG ROCHE DIAGNOSTICS NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1 032 YR Hospitalization| R