BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ACCU-CHEK ® SPIRIT COMBO

    MDR report key: 9803563 · Received March 7, 2020

    Report

    Report Number
    3011393376-2020-00849
    Event Type
    Injury
    Date Received
    March 7, 2020
    Date of Event
    February 7, 2020
    Report Date
    May 6, 2020
    Manufacturer
    ROCHE DIABETES CARE, INC.
    Product Code
    LZG
    UDI-DI
    04015630883479
    PMA / PMN Number
    K111353
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    THE PATIENT REPORTED EXPERIENCING ELEVATED BLOOD GLUCOSE DUE TO INACCURATE INSULIN DELIVERY. ON (B)(6) 2020 HE BEGAN EXPERIENCING ELEVATED BLOOD GLUCOSE OF 200-540 MG/DL, WITH SYMPTOMS OF LETHARGY AND NAUSEA, THAT DID NOT DECREASE DESPITE BOLUSING THROUGH THE PUMP AND CHANGING ACCESSORIES. ON (B)(6) 2020 THE PATIENT'S BLOOD GLUCOSE MEASURED IN THE 400 MG/DL RANGE AT 12:00PM AND HE BOLUSED 15 UNITS OF INSULIN THROUGH THE PUMP. HE WENT TO A "READY MED" CLINIC AND HIS BLOOD GLUCOSE MEASURED OVER 300 MG/DL AT 4:30PM. HE WAS ADVISED TO GO TO THE ER. HIS BLOOD GLUCOSE MEASURED 289 MG/DL AT 5:30-6:00PM IN THE ER. IN THE ER HE WAS TREATED WITH AN IV OF LACTOSE RINGERS AND 2 HOURS LATER HIS BLOOD GLUCOSE WAS STILL IN THE 280 MG/DL RANGE. HE WAS THEN TREATED WITH 6 UNITS OF INSULIN VIA SYRINGE. HE REMAINED IN OBSERVATION IN THE ER UNTIL 2:00AM. HIS BLOOD GLUCOSE MEASURED IN THE 280 MG/DL RANGE AT THE TIME.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    266941 ACCU-CHEK ® SPIRIT COMBO INSULIN INFUSION PUMP LZG ROCHE DIABETES CARE, INC. 05391512001 NA 04015630883479

    Patients

    Seq Age Sex Outcome Treatment
    1 65 YR Hospitalization| R HUMALOG INSULIN U100 VIA INSULIN PUMP