BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LUMIRADX RNA COV-2 STAR COMPLETE

    MDR report key: 14856886 · Received June 29, 2022

    Report

    Report Number
    3012642695-2022-00257
    Event Type
    Malfunction
    Date Received
    June 29, 2022
    Date of Event
    June 2, 2022
    Report Date
    June 29, 2022
    Manufacturer
    LUMIRADX UK LTD.
    Product Code
    QJR
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    CUSTOMER REPORTS EXPERIENCING FALSE NEGATIVES WHEN RUNNING SAMPLES COMPARED TO THEIR OTHER IN HOUSE PCR ASSAY (THERMO FISHER). WAITING FOR DATA FILES, INFORMATION ON CONSUMABLES AND IF THEY ARE RUNNING SAMPLES ON AN LDT. CUSTOMER IS USING THERMO FISHER 7500 FAST, 96. THREE UNITS OF LOT # M2200187 HAVE BEEN PROVIDED TO CUSTOMER TO PERFORM INTERNAL INVESTIGATION AND LOT TO LOT COMPARISON TESTING. AS OF 06/28/2022, CUSTOMER HAS NOT REPORTED FINDINGS OF INTERNAL TROUBLESHOOTING INVESTIGATION AND IS STILL COLLECTING DATA. FIELD APPLICATIONS TEAM WILL CONTINUE TO WORK WITH CUSTOMER TO DETERMINE ROOT CAUSE OF THE ISSUE. PATIENT STATUS WAS NOT REPORTED. NO PATIENT HARM, INJURY OR ADVERSE HEALTH CONSEQUENCES WERE COMMUNICATED BY THE CUSTOMER TO LUMIRADX FOR THE REPORTED EVENT.

    Description of Event or Problem · 0

    CUSTOMER REPORTS EXPERIENCING FALSE NEGATIVES WHEN RUNNING SAMPLES COMPARED TO THEIR OTHER IN HOUSE PCR ASSAY (THERMO FISHER). WAITING FOR DATA FILES, INFORMATION ON CONSUMABLES AND IF THEY ARE RUNNING SAMPLES ON AN LDT. CUSTOMER IS USING THERMO FISHER 7500 FAST, 96.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2473644 LUMIRADX RNA COV-2 STAR COMPLETE LUMIRADX RNA COV-2 STAR COMPLETE QJR LUMIRADX UK LTD. M2200171

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown