BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CONTOUR PLUS

    MDR report key: 11386209 · Received February 26, 2021

    Report

    Report Number
    1810909-2021-00114
    Event Type
    Injury
    Date Received
    February 26, 2021
    Date of Event
    October 17, 2020
    Report Date
    November 4, 2020
    Manufacturer
    ASCENSIA DIABETES CARE US INC.
    Product Code
    NBW
    PMA / PMN Number
    P150001
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MX
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    SECTION B5 OF THE REPORT INDICATED THAT THE METER INVOLVED DURING THE EVENT WAS CONTOUR PLUS. THE ACTUAL METER INVOLVED DURING THE EVENT WAS CONTOUR PLUS LINK 2.4 METER. THE CONTOUR PLUS LINK 2.4 METER IS NOT MARKETED IN UNITED STATES. HOWEVER, THE DEVICE IS SIMILAR TO CONTOUR NEXT LINK 2.4 METER WITH THE PRODUCT CODE NBW AND 510 (K) # P150001, WHICH IS MARKETED IN THE UNITES STATES. SECTIONS B5 AND G4 HAVE BEEN UPDATED.

    Additional Manufacturer Narrative · 0

    THE CUSTOMER DID NOT RETURN THE SUSPECTED DEVICE FOR EVALUATION. THEREFORE, THE IN-HOUSE CONTOUR PLUS LINK 2.4 METER WAS TESTED WITH THE IN-HOUSE CONTOUR PLUS TEST STRIPS FROM LOT#: 9LQHD13A USING A BLOOD SAMPLE, WHICH GAVE A SATISFACTORY PERFORMANCE.

    Description of Event or Problem · 0

    THE CUSTOMER FROM MEXICO REPORTED THAT HE OBTAINED A READING OF 280 MG/DL AT 3:42 P.M. ON THEIR CONTOUR PLUS LINK 2.4 METER. THE CUSTOMER EXPERIENCED A HYPOGLYCEMIC EVENT. THE CUSTOMER STATED THAT HE WAS CONFUSED AND HAD A SEIZURE. THE CUSTOMER'S HYPOGLYCEMIC EVENT WAS MANAGED BY HIS WIFE. NO FURTHER EVENT DETAILS WERE PROVIDED.

    Additional Manufacturer Narrative · 1

    THE PATIENT/FAMILY WAS THE INITIAL REPORTER, SO PERSONAL INFORMATION WAS NOT ENTERED. NO INFORMATION WAS CAPTURED AS THE CUSTOMER'S WEIGHT WAS NOT PROVIDED. THE MODEL # WAS NOT PROVIDED.

    Description of Event or Problem · 1

    THE CUSTOMER FROM (B)(6) REPORTED THAT HE OBTAINED A READING OF 280 MG/DL AT 3:42 P.M. ON THEIR CONTOUR PLUS METER. THE CUSTOMER EXPERIENCED A HYPOGLYCEMIC EVENT. THE CUSTOMER STATED THAT HE WAS CONFUSED AND HAD A SEIZURE. THE CUSTOMER'S HYPOGLYCEMIC EVENT WAS MANAGED BY HIS WIFE. NO FURTHER EVENT DETAILS WERE PROVIDED. 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
    285165 CONTOUR PLUS BLOOD GLUCOSE TEST STRIPS NBW ASCENSIA DIABETES CARE US INC. 9LQHD13A

    Patients

    Seq Age Sex Outcome Treatment
    1 37 YR Male