BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACCU-CHEK ® GUIDE TEST STRIPS

    MDR report key: 17363251 · Received July 20, 2023

    Report

    Report Number
    3011393376-2023-01651
    Event Type
    Malfunction
    Date Received
    July 20, 2023
    Date of Event
    June 28, 2023
    Report Date
    September 19, 2023
    Manufacturer
    ROCHE DIABETES CARE, INC.
    Product Code
    NBW
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PE
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    CUSTOMER HAS TWO VIALS OF ACCU-CHEK GUIDE TEST STRIPS, 1 CURRENT AND 1 EXPIRED, SHE IS NOT SURE WHICH VIAL WAS USED DURING THE EVENT. LOT.103249 EXPIRY 10/14/2023. DATE MFG DATE: (B)(6), 2022. LOT.102739 EXPIRY 01/31/2023. DATE MFG DATE:(B)(6), 2021.

    Description of Event or Problem · 0

    THE CALLER REPORTED THAT THE BLOOD GLUCOSE DEVICE GAVE A HIGHER THAN EXPECTED READING DURING A HYPOGLYCEMIC EVENT. IT WAS REPORTED THAT THE CUSTOMER LOST CONSCIOUSNESS; DURING THIS TIME THE PARAMEDICS TESTED THE CUSTOMER WITH HER GUIDE SYSTEM AND RECEIVED A BLOOD GLUCOSE RESULT OF 126 MG/DL. THE PARAMEDICS TREATED THE CUSTOMER, HOWEVER THE TYPE OF TREATMENT PROVIDED WAS UNKNOWN. THE CUSTOMER REPORTED THAT SHE HAS TWO VIALS OF TEST STRIPS AND ONE VIAL IS EXPIRED. THE CUSTOMER WAS NOT SURE WHICH VIAL THE PARAMEDIC'S USED TO TEST HER BLOOD GLUCOSE. THE CUSTOMER RECOVERED AT HOME AND WAS NOT TRANSPORTED TO THE HOSPITAL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    39973 ACCU-CHEK ® GUIDE TEST STRIPS BLOOD GLUCOSE MONITORING TEST STRIPS NBW ROCHE DIABETES CARE, INC. 103249

    Patients

    Seq Age Sex Outcome Treatment
    1 Female