BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CONTOUR PLUS LINK 2.4

    MDR report key: 8850225 · Received August 1, 2019

    Report

    Report Number
    1810909-2019-00325
    Event Type
    Malfunction
    Date Received
    August 1, 2019
    Date of Event
    July 4, 2019
    Report Date
    July 4, 2019
    Manufacturer
    ASCENSIA DIABETES CARE US INC.
    Product Code
    NBW
    PMA / PMN Number
    P150001
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IS
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    ASCENSIA DIABETES CARE HAVE CONFIRMED THAT 300 MMOL/L BULK METERS WERE MISS-KITTED AT THE PACKAGER. OF THESE 300 INCORRECTLY KITTED METERS, MEDTRONIC HAS CONFIRMED THAT 27 METERS ARE WITH THE CUSTOMERS AND REMAINING METERS ARE UNDER THE DISTRIBUTOR'S CONTROL. THE METER INVOLVED IN THIS EVENT IS CONTOUR PLUS LINK 2.4, WHICH 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. THE CUSTOMER DETAILS WERE NOT PROVIDED, THEREFORE, NO INFORMATION WAS CAPTURED. THE EXACT EVENT DATE WAS NOT PROVIDED, THEREFORE, DATE ASCENSIA WAS INFORMED ABOUT THE EVENT WAS CAPTURED AS THE EVENT DATE. THE DEVICE IDENTIFIER # WAS LEFT BLANK AS IT COULD NOT BE DETERMINED BASED ON THE AVAILABLE MODEL #. MDR 1810909-2019-00324 HAS BEEN FILED FOR SERIAL # (B)(4) AND MDR 1810909-2019-00326 HAS BEEN FILED FOR SERIAL # (B)(4).

    Description of Event or Problem · 1

    ASCENSIA DIABETES CARE WAS INFORMED BY MEDTRONIC ISRAEL THAT SOME OF THE CONTOUR PLUS LINK 2.4 DEVICES HAD UNITS OF MEASUREMENT AS MMOL/L, ALTHOUGH, THE PACKAGING INDICATED THAT THEY WERE DESIGNATED TO REPORT RESULTS IN MG/DL. ACCORDING TO MEDTRONIC ISRAEL'S INITIAL REPORT, ALL THESE DEVICES WERE FROM THE SAME BATCH DP07N014P. THE ISSUE WAS DISCOVERED BY THE FIELD REPRESENTATIVE OF MEDTRONIC WHEN THEY FAILED TO PAIR THE INSULIN PUMP WITH THE GLUCOSE METER. THE FIELD REPRESENTATIVE HAD 3 METERS IN THEIR POSSESSION (SERIAL #S (B)(4)).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    647001 CONTOUR PLUS LINK 2.4 BLOOD GLUCOSE METER NBW ASCENSIA DIABETES CARE US INC. 6246

    Patients

    Seq Age Sex Outcome Treatment
    1