BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CONTOUR® NEXT GEN

    MDR report key: 22106374 · Received May 29, 2025

    Report

    Report Number
    1810909-2025-00080
    Event Type
    Malfunction
    Date Received
    May 29, 2025
    Date of Event
    May 2, 2025
    Report Date
    August 4, 2025
    Manufacturer
    ASCENSIA DIABETES CARE US INC.
    Product Code
    NBW
    PMA / PMN Number
    K241787
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THE ROOT CAUSE FOR THIS ISSUE WAS IDENTIFIED AT THE THIRD-PARTY PACKAGING SITE (PHC INDONESIA). CONTOUR® NEXT GEN BLOOD GLUCOSE METERS WERE NOT RE-CONFIGURED WITH UNITS OF MEASUREMENT FOR CANADA (WHICH SHOULD BE IN MMOL/L) AND PASSED ALONG THE PACKAGING LINE UNDETECTED. THEREFORE, THE METERS WITH INCORRECT UNITS OF MEASUREMENT WERE USED FOR THE LOT DESTINED FOR THE CANADIAN MARKET. AN URGENT MEDICAL DEVICE RECALL (UMDR) NOTICE WAS SENT TO THE CANADIAN CUSTOMERS ON 10-JUL-2025. THE RECALL NOTIFICATION INCLUDED A DESCRIPTION OF THE REASON FOR THE RECALL, AFFECTED PRODUCT, CONSIGNEE RESPONSIBILITIES, AND INSTRUCTIONS FOR RESPONDING TO THE FORMAL RECALL NOTIFICATION. CUSTOMERS ARE INSTRUCTED TO CONTACT ASCENSIA DIABETES CARE CUSTOMER SERVICE TO RETURN THE AFFECTED PRODUCT AND RECEIVE THE REPLACEMENT PRODUCT. THE UMDR EXPLAINED THE POTENTIAL RISK FOR INCORRECT UNITS OF MEASUREMENT ASSOCIATED WITH THE CONTOUR® NEXT GEN METERS. PHC INDONESIA HAS IMPLEMENTED IMPROVEMENTS TO RESOLVE THE ISSUE OF INCORRECT UNITS OF MEASUREMENT. SINCE THE ISSUE WAS ASSOCIATED WITH THE PACKAGING OF THE DEVICE, THE DEVICE MANUFACTURE DATE IN SECTION H4 HAS BEEN CAPTURED AS 31-OCT-2024, WHEN THE SUSPECTED DEVICE WAS PACKAGED AT PHC INDONESIA.

    Additional Manufacturer Narrative · 0

    NO INFORMATION WAS PROVIDED FOR THE INITIAL REPORTER, SO NO INFORMATION WAS ENTERED IN SECTION E1. NO INFORMATION WAS CAPTURED IN SECTIONS A2 AND A4 AS THE CUSTOMER'S AGE AND WEIGHT WERE NOT PROVIDED. THE CONTOUR® NEXT GEN 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 CONTOUR® NEXT GEN METER WITH SKU # 7923 AND SERIAL # (B)(6) WAS DISTRIBUTED OUTSIDE THE US, THEREFORE, NO GUDID INFORMATION EXISTS AND THE UDI NUMBER IS NOT APPLICABLE.

    Description of Event or Problem · 0

    A HEALTHCARE PROFESSIONAL (HCP) CONTACTED ASCENSIA CUSTOMER SERVICE ON BEHALF OF THE CUSTOMER TO REPORT THAT THEY PROVIDED A CONTOUR® NEXT GEN METER TO THE CUSTOMER, WHICH WAS DISPLAYING THE UNITS OF MEASUREMENT ACCOMPANIED WITH THE BLOOD GLUCOSE READINGS IN MG/DL INSTEAD OF MMOL/L. THERE WAS NO ALLEGATION OF AN ADVERSE EVENT. THE HCP 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
    625628 CONTOUR® NEXT GEN BLOOD GLUCOSE METER NBW ASCENSIA DIABETES CARE US INC. 7923 PH24110008

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Female