BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACCU-CHEK ® GUIDE TEST STRIPS

    MDR report key: 14377351 · Received May 12, 2022

    Report

    Report Number
    3011393376-2022-01440
    Event Type
    Malfunction
    Date Received
    May 12, 2022
    Date of Event
    April 27, 2022
    Report Date
    June 2, 2022
    Manufacturer
    ROCHE DIABETES CARE, INC.
    Product Code
    NBW
    UDI-DI
    00365702701953
    PMA / PMN Number
    K160944
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KY, US
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    THIS CASE, WITH PATIENT IDENTIFIER (B)(6) (SYSTEM 1; TEST STRIP LOT NUMBER 103081), IS RELATED TO CASE WITH PATIENT IDENTIFIER (B)(6) (SYSTEM 2; UNKNOWN TEST STRIP LOT NUMBER).

    Description of Event or Problem · 0

    ON (B)(6) 2022, THE PATIENT RECEIVED THE FOLLOWING RESULTS WITHIN 15 MINUTES: 28 MG/DL (SYSTEM 1; TEST STRIP LOT NUMBER 103081) AND A READING BETWEEN "109-120 MG/DL" (SYSTEM 2; UNKNOWN TEST STRIP LOT NUMBER). THE PATIENT COULD NOT RECALL THE EXACT VALUES. ON (B)(6) 2022, THE PATIENT RECEIVED THE FOLLOWING RESULTS WITHIN 15 MINUTES: 43 MG/DL (SYSTEM 1; TEST STRIP LOT NUMBER 103081) AND 129 MG/DL (SYSTEM 1; TEST STRIP LOT NUMBER 103081). ON (B)(6) 2022, THE PATIENT RECEIVED THE FOLLOWING RESULTS WITHIN 15 MINUTES: 20 MG/DL (SYSTEM 1; TEST STRIP LOT NUMBER 103081) AND 97 MG/DL (SYSTEM 1; TEST STRIP LOT NUMBER 103081).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1114409 ACCU-CHEK ® GUIDE TEST STRIPS BLOOD GLUCOSE MONITORING TEST STRIPS NBW ROCHE DIABETES CARE, INC. 07453736001 103081 00365702701953

    Patients

    Seq Age Sex Outcome Treatment
    1 60 YR Female