BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACCU-CHEK ® GUIDE TEST STRIPS

    MDR report key: 16377072 · Received February 15, 2023

    Report

    Report Number
    3011393376-2023-00420
    Event Type
    Malfunction
    Date Received
    February 15, 2023
    Date of Event
    February 12, 2023
    Report Date
    March 17, 2023
    Manufacturer
    ROCHE DIABETES CARE, INC.
    Product Code
    NBW
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    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.

    Additional Manufacturer Narrative · 0

    SECTION D4: UPDATED THE SUSPECT MEDICAL DEVICE SECTION WITH THE VIAL OF TEST STRIPS (LOT 103549) THAT WERE RETURNED FOR EVALUATION. THE 2ND VIAL INVOLVED (LOT 103393 ) WERE NOT RETURNED, THEREFORE NO INVESTIGATION IS POSSIBLE.

    Description of Event or Problem · 0

    IT WAS REPORTED THE PATIENT RECEIVED THE FOLLOWING RESULTS WITHIN 15 MINUTES: 20:35 213MG/DL. 20:43 125MG/DL. 20:56 181MG/DL. 20:57 HI MG/DL (WHICH ON THE SYSTEM INDICATES A RESULT IN EXCESS OF 600 MG/DL). 20:58 132MG/DL. READINGS OCCURRED WITH TWO DIFFERENT VIALS OF TEST STRIPS (LOT 103393/EXPIRY 12/28/2023 AND LOT 103549/EXPIRY 03/07/2024 . CUSTOMER IS NOT SURE WHICH TEST STRIPS PRODUCED EACH RESULT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1140445 ACCU-CHEK ® GUIDE TEST STRIPS BLOOD GLUCOSE MONITORING TEST STRIPS NBW ROCHE DIABETES CARE, INC. 103549

    Patients

    Seq Age Sex Outcome Treatment
    1 81 YR Male