BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CONTOUR® PLUS BLUE

    MDR report key: 22701941 · Received August 4, 2025

    Report

    Report Number
    1810909-2025-00117
    Event Type
    Malfunction
    Date Received
    August 4, 2025
    Date of Event
    July 16, 2025
    Report Date
    February 13, 2026
    Manufacturer
    ASCENSIA DIABETES CARE US INC.
    Product Code
    NBW
    UDI-DI
    00301937036019
    PMA / PMN Number
    K231679
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    THE CUSTOMER RETURNED A CONTOUR® PLUS BLUE METER (SERIAL # (B)(6)) AND CONTOUR® PLUS TEST STRIPS (LOT # 4EQHH01A) FOR EVALUATION. DURING INVESTIGATION, THE METER SWITCHED ON AS EXPECTED AND NO ANOMALIES WERE OBSERVED WHEN CUSTOMER SERVICE MODE WAS RUN. THREE CONTROL TESTS WERE CONDUCTED USING THE RETURNED METER, IN-HOUSE CONTOUR® PLUS TEST STRIPS FROM THE SAME LOT (4EQHH01A), AND IN-HOUSE CONTOUR® PLUS CONTROL SOLUTION (LOT # 5BV2R40). THE RESULTS WERE 129 MG/DL, 134 MG/DL, AND 132 MG/DL, ALL WITHIN THE EXPECTED CONTROL RANGE OF 113-141 MG/DL. A REVIEW OF THE METER'S MEMORY DID NOT REVEAL ANY RECORD OF A 55 MG/DL READING, WHICH THE CUSTOMER REPORTED AS A MISSING RESULT. ADDITIONALLY, THE METER WAS TESTED USING AN IN-HOUSE CONTOUR® PLUS TEST FIXTURE SIMULATING A BLOOD GLUCOSE VALUE OF 77 MG/DL. THIS SIMULATED TEST WAS SUCCESSFULLY RECORDED IN THE METER'S MEMORY WITH THE CORRECT DATE AND TIME. BASED ON THE INVESTIGATION, THE METER WAS FOUND TO BE FUNCTIONING AS EXPECTED. THE PATIENT/FAMILY (A1) WAS THE INITIAL REPORTER (E1), SO PERSONAL INFORMATION WAS NOT ENTERED. NO INFORMATION WAS CAPTURED IN SECTIONS A2 AND A4 AS THE CUSTOMER'S AGE AND WEIGHT WERE NOT PROVIDED. THE CONTOUR® PLUS BLUE METER DOES NOT HAVE AN EXPIRATION DATE. THEREFORE, NO INFORMATION WAS CAPTURED IN SECTION D4 (EXPIRATION DATE). THE WARRANTY PERIOD OF THE METER IS 5 YEARS FROM THE DATE OF THE ORIGINAL PURCHASE.

    Additional Manufacturer Narrative · 0

    AN IN-HOUSE TESTING WAS PERFORMED WITH THE RETURNED CONTOUR® PLUS BLUE METER (SERIAL # (B)(6)) AND RETURNED CONTOUR® PLUS TEST STRIPS (LOT # 4EQHH01A) USING BLOOD SPIKED WITH GLUCOSE AT 131 MG/DL, AS DETERMINED BY YSI INSTRUMENT IN FIVE REPLICATES. ALL TESTS RECOVERED WITHIN FIT-FOR-USE LIMITS. THE BLOOD GLUCOSE RESULTS OBTAINED WITH THE IN-HOUSE TESTING WERE PROPERLY STORED IN THE METER'S MEMORY.

    Additional Manufacturer Narrative · 0

    SECTION H3 HAS BEEN UPDATED FROM "NO" TO "YES".

    Description of Event or Problem · 0

    THE CUSTOMER REPORTED THAT ONE OF HIS BLOOD GLUCOSE READINGS WAS NOT STORED IN THE MEMORY OF THE CONTOUR® PLUS BLUE METER. THERE WAS NO ALLEGATION OF AN ADVERSE EVENT. 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
    1571357 CONTOUR® PLUS BLUE BLOOD GLUCOSE METER NBW ASCENSIA DIABETES CARE US INC. 7036 PH24090006 00301937036019

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Female