BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ACCU-CHEK ® PERFORMA COMBO

    MDR report key: 8703535 · Received June 17, 2019

    Report

    Report Number
    3011393376-2019-02126
    Event Type
    Injury
    Date Received
    June 17, 2019
    Date of Event
    May 25, 2019
    Report Date
    July 23, 2025
    Manufacturer
    ROCHE DIABETES CARE, INC.
    Product Code
    NBW
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AR
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 1

    THE EVENT OCCURRED OUTSIDE OF THE UNITED STATES. WHILE THIS PRODUCT IS NOT SOLD IN THE UNITED STATES, IT IS LIKE OR SIMILAR TO A PRODUCT MARKETED IN THE UNITED STATES.

    Description of Event or Problem · 1

    THE CALLER REPORTED THAT THE BOLUS RECOMMENDATIONS PROVIDED BY THE BLOOD GLUCOSE MONITOR WERE NOT ACCURATE, WHICH LED TO A HYPOGLYCEMIC EVENT. AT 11:15 AM THE PATIENT RECEIVED A BLOOD GLUCOSE RESULT OF 303 MG/DL AND A BOLUS RECOMMENDATION OF 16 UNITS. AT 1:22 PM THE PATIENT RECEIVED A RESULT OF 200 MG/DL AND A BOLUS RECOMMENDATION OF 16 UNITS. AT 5:10 PM HE RECEIVED A RESULT OF 73 MG/DL AND NO RECOMMENDATION OR UNITS WERE APPLIED. AT 8:00 PM THE PATIENT RECEIVED A BLOOD GLUCOSE RESULT OF 33 MG/DL AND BECAME UNCONSCIOUS. THE EMT'S WERE CALLED AND TRANSPORTED THE PATIENT TO THE HOSPITAL. IT WAS REPORTED THAT THE HOSPITAL TREATED THE PATIENT WITH "NPH", BUT THAT HE DID NOT AGREE WITH THE TREATMENT. THE PATIENT WAS HOSPITALIZED FOR 3 DAYS AND IS CURRENTLY STABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    499209 ACCU-CHEK ® PERFORMA COMBO BLOOD GLUCOSE MONITORING DEVICE NBW ROCHE DIABETES CARE, INC. NA

    Patients

    Seq Age Sex Outcome Treatment
    1 63 YR Male Hospitalization| R UNKNOWN INSULIN| UNKNOWN INSULIN