BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CONTOUR® PLUS

    MDR report key: 23243058 · Received October 8, 2025

    Report

    Report Number
    1810909-2025-00152
    Event Type
    Malfunction
    Date Received
    October 8, 2025
    Date of Event
    September 9, 2025
    Report Date
    December 15, 2025
    Manufacturer
    ASCENSIA DIABETES CARE US INC.
    Product Code
    NBW
    PMA / PMN Number
    K191286
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CH
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THE INITIAL REPORTER'S CONTACT DETAILS WERE NOT PROVIDED; THEREFORE, THIS INFORMATION WAS NOT CAPTURED IN SECTION E1. UNKNOWN WAS RECORDED IN SECTION A1, AND NO INFORMATION WAS CAPTURED IN SECTIONS A2, A3 AND A4, AS THE PATIENT'S CREDENTIALS, AGE, SEX AND WEIGHT WERE NOT PROVIDED. 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. THE CONTOUR® PLUS TEST STRIPS WITH SKU # 7662 AND LOT # 4DQHH07A HAS THE 510K # K191286 AND UDI # (B)(4). THE DEVICE WAS DISTRIBUTED OUTSIDE THE US, THEREFORE, NO GUDID INFORMATION EXISTS.

    Additional Manufacturer Narrative · 0

    THE CUSTOMER RETURNED A SUSPECTED CONTOUR® PLUS METER (SERIAL # (B)(6)) AND CONTOUR® PLUS TEST STRIPS FROM LOT 4DQHH07A FOR EVALUATION. IN-HOUSE TESTING WAS PERFORMED WITH THE RETURNED METER AND STRIPS USING BLOOD SPIKED WITH GLUCOSE AT 22.34 MMOL/L AND 3.74 MMOL/L, AS DETERMINED BY A YSI INSTRUMENT, IN FIVE REPLICATES EACH. ALL REPLICATES WERE OUTSIDE OF FIT-FOR-USE LIMITS. ADDITIONALLY, ERROR MESSAGES WERE OBSERVED, INCLUDING E11 (INDICATIVE OF ABNORMAL RESULT), E3 (INDICATIVE OF USED TEST STRIP), AND LO (INDICATIVE OF RESULTS BELOW 0.6 MMOL/L). THE RETURNED TEST STRIPS WERE SENT TO PHC, THE STRIP SUPPLIER, FOR FURTHER EVALUATION. THE ISSUES OF LOW RESULTS AND ERROR MESSAGES WERE REPRODUCED. TESTING WITH RETENTION SAMPLES FROM THE SAME LOT OF TEST STRIPS DEMONSTRATED SATISFACTORY PERFORMANCE, AND REVIEW OF DEVICE HISTORY RECORDS REVEALED NO MANUFACTURING ISSUES. GAS CHROMATOGRAPHY ANALYSIS OF THE RETURNED STRIPS IDENTIFIED CONTAMINATION WITH ETHANOL, PALMITIC ACID, AND SQUALENE. ETHANOL, COMMONLY FOUND IN DISINFECTANTS, IS HIGHLY LIKELY TO HAVE DETERIORATED THE REAGENT, CAUSING LOW RESULTS. PALMITIC ACID AND SQUALENE ARE COMPONENTS OF SEBUM. IF THE CUSTOMER USED HAND SANITIZER AFTER WASHING HANDS AND BEFORE MEASUREMENT AND TOUCHED THE TEST STRIPS OR THE INSIDE OF THE STRIP VIAL BEFORE THE SANITIZER DRIED COMPLETELY, THE REAGENT COULD HAVE DETERIORATED DUE TO EXPOSURE TO THESE SUBSTANCES.

    Description of Event or Problem · 0

    A HEALTHCARE PROFESSIONAL (HCP) FROM CHINA REPORTED THAT A PATIENT'S BLOOD SAMPLE WAS TESTED USING THE CONTOUR® PLUS METER, YIELDING A BLOOD GLUCOSE READING OF 0.8 MMOL/L. THE HCP PERFORMED A SECOND BLOOD GLUCOSE TEST USING AN ALTERNATE CONTOUR® PLUS METER AND THE SAME LOT OF TEST STRIPS, WHICH ALSO PRODUCED A LOW READING. NO SPECIFIC VALUE WAS PROVIDED. SUBSEQUENTLY, LABORATORY TESTING WAS PERFORMED, AND A READING OF 8.2 MMOL/L WAS OBTAINED. THERE WAS NO ALLEGATION OF AN ADVERSE EVENT. THE NURSE WAS ADVISED TO RETURN THE DEVICE FOR EVALUATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2509383 CONTOUR® PLUS BLOOD GLUCOSE TEST STRIPS NBW ASCENSIA DIABETES CARE US INC. 7662 4DQHH07A

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown