BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CONTOUR® PLUS

    MDR report key: 21423155 · Received February 20, 2025

    Report

    Report Number
    1810909-2025-00029
    Event Type
    Malfunction
    Date Received
    February 20, 2025
    Date of Event
    January 29, 2025
    Report Date
    May 22, 2025
    Manufacturer
    ASCENSIA DIABETES CARE US INC.
    Product Code
    JJX
    PMA / PMN Number
    K151742
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MX
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    AS PER THE CONTOUR® PLUS CONTROL SOLUTION USER MANUAL, SQUEEZE A SMALL DROP OF SOLUTION ONTO A CLEAN, NON-ABSORBENT SURFACE. THE CUSTOMER DID NOT FOLLOW THIS INSTRUCTION. 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. MODEL # 7707 OF THE CONTOUR® PLUS CONTROL SOLUTION IS ONLY AVAILABLE IN MEXICO; THEREFORE, THE UDI # IS NOT APPLICABLE. CONTOUR® PLUS CONTROL SOLUTION IS SIMILAR TO THE CONTOUR® NEXT CONTROL SOLUTION AVAILABLE IN US MARKET. THEREFORE, PRODUCT CODE JJX AND MOST RECENT 510 (K) # K151742 ASSOCIATED WITH THE CONTOUR® NEXT CONTROL SOLUTION MARKETED IN US WERE CAPTURED IN SECTIONS D2B AND G4 RESPECTIVELY. THE DEVICE WAS DISTRIBUTED OUTSIDE THE US, THEREFORE, NO GUDID INFORMATION EXISTS.

    Additional Manufacturer Narrative · 0

    THE CUSTOMER DID NOT RETURN THE DEVICE FOR INVESTIGATION. THEREFORE, THE IN-HOUSE CONTOUR® NEXT METER WITH SERIAL (B)(6) AND THE IN-HOUSE CONTOUR® NEXT TEST STRIPS FROM LOT # 3MPEF04C WERE USED FOR IN-HOUSE TESTING, USING BLOOD SPIKED WITH GLUCOSE AT 21.9 MMOL/L AND 7.5 MMOL/L, AS DETERMINED BY THE YSI INSTRUMENT IN FIVE REPLICATES EACH. ALL TESTS RECOVERED WITHIN THE FIT-FOR-USE LIMITS.

    Additional Manufacturer Narrative · 0

    THE CUSTOMER DID NOT RETURN THE SUSPECTED DEVICE FOR EVALUATION. THEREFORE, AN IN-HOUSE CONTOUR® PLUS METER WITH SERIAL # (B)(6), IN-HOUSE CONTOUR® PLUS TEST STRIPS FROM LOT # 3GQHH13A AND IN-HOUSE CONTOUR® PLUS CONTROL SOLUTION FROM LOT # 4BV2S08 WERE USED FOR IN-HOUSE TESTING IN FIVE REPLICATES. ALL CONTROL TESTS WERE REPRODUCIBLE AND FELL WITHIN THE CONTROL RANGES OF 110 MG/DL TO 143 MG/DL. THE CONTROL RESULTS OBTAINED WITH THE IN-HOUSE TESTING WERE PROPERLY MARKED AS CONTROL RESULTS. IN SECTION D4 OF THE INITIAL REPORT, THE LOT # OF THE CONTOUR® PLUS CONTROL SOLUTION WAS INCORRECTLY CAPTURED AS 4BV2F08. THE CORRECT LOT NUMBER IS 4BV2S08. SECTION D4 HAS BEEN UPDATED TO REFLECT THIS CORRECTION. THE FIRST SUPPLEMENTAL REPORT, MDR # 1810909-2025-00029S, SUBMITTED ON 28-MAR-2025, WAS FILED INADVERTENTLY. THE INFORMATION CONTAINED IN THAT REPORT PERTAINS TO MDR # 1810909-2025-00028. THE CORRECT SUPPLEMENTAL INFORMATION FOR MDR # 1810909-2025-00028 WAS SUBMITTED ON 14-MAY-2025.

    Description of Event or Problem · 0

    AN ADVOCATE FROM MEXICO CALLED ON BEHALF OF THE CUSTOMER TO REPORT THAT THE CUSTOMER RAN A CONTROL TEST WITH THE CONTOUR® PLUS METER AND OBTAINED A READING OF 148 MG/DL AT 3:46 P.M. THE METER DID NOT AUTOMATICALLY MARK IT AS CONTROL TEST, AND SO THE READING WILL BE DISPLAYED AS A BLOOD RESULT WHEN ACCESSING THE METER'S MEMORY. THERE WAS NO ALLEGATION OF AN ADVERSE EVENT. THE ADVOCATE 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
    1037183 CONTOUR® PLUS QUALITY CONTROL MATERIAL JJX ASCENSIA DIABETES CARE US INC. 7707 4BV2S08

    Patients

    Seq Age Sex Outcome Treatment
    1 62 YR Female