BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    AMNISURE ROM TEST

    MDR report key: 7346899 · Received March 16, 2018

    Report

    Report Number
    1122376-2018-00003
    Event Type
    Malfunction
    Date Received
    March 16, 2018
    Date of Event
    May 4, 2018
    Report Date
    May 30, 2018
    Manufacturer
    QIAGEN SCIENCES, LLC
    Product Code
    NQM
    PMA / PMN Number
    K081767
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    SINCE THE INITIAL MEDICAL DEVICE REPORT SUBMISSION, QIAGEN HAS TESTED OVER 900 TEST STRIPS FROM THE COMPLAINANT'S KIT LOT, 557016546. TO DATE, NO INVALID RESULTS HAVE BEEN OBSERVED ON RETAINED TEST STRIPS, AND 69 INVALID RESULTS HAVE BEEN OBSERVED ON TEST STRIPS RETURNED FROM CUSTOMERS AND QIAGEN'S THIRD PARTY LOGISTICS (3PL) LOCATION. THIS LOT EXHIBITS A HIGHER THAN EXPECTED RATE OF INVALID RESULTS. QIAGEN HAS INITIATED A VOLUNTARY PRODUCT RECALL OF KIT LOTS CONTAINING THE SAME TEST STRIP LOT (FMRT-1-25-US KIT LOTS 55701646, 557016547, 5600115 AND FMRT-1-25-CA KIT LOT 557016409). WE ARE INSTRUCTING CUSTOMERS TO DISCONTINUE USE OF THESE LOTS AND TO RETURN ANY UNUSED INVENTORY TO QIAGEN. THIS FIELD ACTION WAS REPORTED TO ORA AS QIAGEN RECALL #1122376-05/18/2018-001R. FURTHER UPDATES WILL BE PROVIDED TO ORA. THE ROOT CAUSE FOR THE INVALID TESTS IS STILL UNDER INVESTIGATION.

    Description of Event or Problem · 0

    ON FEBRUARY 19TH, QIAGEN RECEIVED FROM FDA, MEDWATCH REPORT #(B)(4), WHICH WAS SUBMITTED BY (B)(6). THE CUSTOMER REPORTED THREE INVALID TESTS (NO CONTROL LINE PRESENT) OCCURED ON (B)(6) 2018.

    Additional Manufacturer Narrative · 1

    A MAUDE REPORT WAS COMMUNICATED TO QIAGEN THAT STATED 3 TEST STRIPS DID NOT SHOW A CONTROL LINE RESULTING IN INVALID TESTS. CUSTOMER RETURNS WERE REQUESTED AND TESTED ALONG WITH COMPANY RETAIN SAMPLES ON (B)(6) 2018. THE REPORTED PROBLEM WAS CONFIRMED WITH THE CUSTOMER'S RETURNED PRODUCT WHERE 5 OUT OF 16 TEST STRIPS TESTED HAD NO VISIBLE CONTROL LINE. THE REPORTED PROBLEM WAS NOT CONFIRMED WITH RETAINED PRODUCT WHERE 25 OUT OF 25 TEST STRIPS TESTED ALL HAD VISIBLE CONTROL LINES. ALL AVAILABLE INVENTORY CONTAINING THESE TEST STRIPS HAS BEEN PLACED ON HOLD UNTIL FURTHER INVESTIGATION CAN BE COMPLETED.

    Description of Event or Problem · 1

    ON (B)(6), QIAGEN RECEIVED FROM FDA, MEDWATCH REPORT #(B)(4), WHICH WAS SUBMITTED BY (B)(6) HOSPITAL OF (B)(6). THE CUSTOMER REPORTED THREE INVALID TESTS (NO CONTROL LINE PRESENT) OCCURED ON (B)(6) 2018.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    188595 AMNISURE ROM TEST AMNISURE ROM TEST NQM QIAGEN SCIENCES, LLC FMRT-1 557016546

    Patients

    Seq Age Sex Outcome Treatment
    1