BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CONTOUR® PLUS

    MDR report key: 22028588 · Received May 15, 2025

    Report

    Report Number
    1810909-2025-00077
    Event Type
    Injury
    Date Received
    May 15, 2025
    Date of Event
    January 23, 2025
    Report Date
    July 16, 2025
    Manufacturer
    ASCENSIA DIABETES CARE US INC.
    Product Code
    NBW
    PMA / PMN Number
    K191286
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MX
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    A DEVICE HISTORY RECORD WAS REVIEWED FOR THE SUSPECTED CONTOUR® PLUS METER WITH SERIAL # (B)(6) AND NO MANUFACTURING ANOMALIES WERE FOUND.

    Additional Manufacturer Narrative · 0

    THE CUSTOMER USED CONTOUR® PLUS TEST STRIPS FROM LOT # 2HQHH06C WHICH EXPIRED IN AUG-2024. AS PER THE CONTOUR® PLUS METER USER GUIDE, "DO NOT USE EXPIRED MATERIALS. USING EXPIRED MATERIAL CAN CAUSE INACCURATE RESULTS. ALWAYS CHECK THE EXPIRATION DATES ON YOUR TEST STRIPS." ADDITIONALLY, A DEVICE HISTORY RECORD WAS REVIEWED FOR THE SUSPECTED CONTOUR PLUS TEST STRIPS AND NO MANUFACTURING ANOMALIES WERE FOUND. THE PATIENT/FAMILY (A1) WAS THE INITIAL REPORTER (E1), SO PERSONAL INFORMATION WAS NOT ENTERED. NO INFORMATION WAS CAPTURED IN SECTION A4 AS THE CUSTOMER'S WEIGHT WAS NOT PROVIDED. SKU # 7706 OF THE CONTOUR® PLUS TEST STRIPS IS ONLY AVAILABLE IN MEXICO; THEREFORE, THE UDI # IS NOT APPLICABLE. THE CONTOUR® PLUS TEST STRIPS USED WITH THE CONTOUR® PLUS METER IS SIMILAR TO THE CONTOUR® NEXT TEST STRIPS USED WITH THE CONTOUR® NEXT METER AVAILABLE IN THE US MARKET. THEREFORE, PRODUCT CODE NBW AND MOST RECENT 510 (K) # K191286 ASSOCIATED WITH THE CONTOUR® NEXT METER MARKETED IN US WERE CAPTURED IN SECTIONS D2B AND G4 RESPECTIVELY. THE DEVICE WAS DISTRIBUTED OUTSIDE THE US, THEREFORE, NO GUDID INFORMATION EXISTS.

    Description of Event or Problem · 0

    THE CUSTOMER FROM MEXICO REPORTED THAT SHE OBTAINED BLOOD GLUCOSE READINGS OF 191 MG/DL AT 3:28 P.M. AND 92 MG/DL AT 3:30 P.M. WITH THE CONTOUR® PLUS METER. THE CUSTOMER WAS EXPERIENCING SYMPTOMS OF HYPERGLYCEMIA WHICH WAS DESCRIBED AS BLURRY VISION, DIZZINESS AND HEADACHE. THE CUSTOMER VISITED A DOCTOR WHO PERFORMED A BLOOD GLUCOSE TEST WITH AN ALTERNATE METER AND OBTAINED A READING OF 380 MG/DL. THE CUSTOMER WAS GIVEN AN INTRAVENOUS INFUSION OF INSULIN IN THE HOSPITAL, WHERE THEY STAYED FOR 4 TO 5 HOURS. FOLLOWING THE TREATMENT, THE CUSTOMER'S GLUCOSE LEVELS WERE STABILIZED. THE DOCTOR ADVISED HER TO EXERCISE AND AVOID HIGH-CARBOHYDRATE FOODS. THE CUSTOMER WAS ADVISED TO RETURN THE DEVICE FOR EVALUATION. A REPLACEMENT METER KIT WAS SENT TO THE CUSTOMER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2011114 CONTOUR® PLUS BLOOD GLUCOSE TEST STRIPS NBW ASCENSIA DIABETES CARE US INC. 7706 2HQHH06C

    Patients

    Seq Age Sex Outcome Treatment
    1 54 YR Female Required Intervention| H