BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CONTOUR® PLUS ELITE

    MDR report key: 21504290 · Received March 3, 2025

    Report

    Report Number
    1810909-2025-00033
    Event Type
    Malfunction
    Date Received
    March 3, 2025
    Date of Event
    February 4, 2025
    Report Date
    May 22, 2025
    Manufacturer
    ASCENSIA DIABETES CARE US INC.
    Product Code
    NBW
    PMA / PMN Number
    K223293
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MX
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    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. THE CONTOUR® PLUS ELITE 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. THE KIT # ASSOCIATED WITH THE METER IS NOT AVAILABLE. IF THE INFORMATION IS AVAILABLE AT THE LATER DATE, IT WILL BE PROVIDED IN THE SUPPLEMENTAL REPORT. SKU # 7888 OF THE CONTOUR® PLUS ELITE METER IS ONLY AVAILABLE IN MEXICO; THEREFORE, THE UDI # IS NOT APPLICABLE. CONTOUR® PLUS ELITE METER IS SIMILAR TO THE CONTOUR® NEXT GEN METER AVAILABLE IN US MARKET. THEREFORE, PRODUCT CODE NBW AND MOST RECENT 510 (K) # K223293 ASSOCIATED WITH THE CONTOUR® NEXT GEN METER 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

    DESPITE THE FOLLOW-UP ATTEMPT, THE CUSTOMER DID NOT RETURN THE DEVICE FOR EVALUATION. THEREFORE, A DEVICE HISTORY RECORD WAS REVIEWED FOR THE SUSPECTED CONTOUR® PLUS ELITE METER WITH SERIAL # (B)(6), AND NO MANUFACTURING ANOMALIES WERE FOUND. THE KIT LOT # FOR THE CONTOUR® PLUS ELITE METER WITH SERIAL # (B)(6) HAS BEEN UPDATED IN SECTION D4.

    Description of Event or Problem · 0

    AN ADVOCATE FROM MEXICO CALLED ASCENSIA CUSTOMER SERVICE ON BEHALF OF THE CUSTOMER TO SEEK ASSISTANCE WITH THE CONTOUR® PLUS ELITE METER. DURING THE TROUBLESHOOTING, IT WAS FOUND THAT THE CUSTOMER'S BLOOD GLUCOSE READINGS WERE NOT BEING STORED IN 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
    806647 CONTOUR® PLUS ELITE BLOOD GLUCOSE METER NBW ASCENSIA DIABETES CARE US INC. 7888 DP02U020P

    Patients

    Seq Age Sex Outcome Treatment
    1 71 YR Male