BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LUMIRADX RNA COV-2 STAR COMPLETE

    MDR report key: 14702942 · Received June 15, 2022

    Report

    Report Number
    3012642695-2022-00250
    Event Type
    Malfunction
    Date Received
    June 15, 2022
    Date of Event
    May 2, 2022
    Report Date
    June 15, 2022
    Manufacturer
    LUMIRADX UK LTD.
    Product Code
    QJR
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    CUSTOMER STATED BATCHES M2200191 AND M2200215 APPEARED TO BE CONTAMINATED. EVERY TESTED SAMPLE IS BECAME POSITIVE DURING TESTING. ACTIONS ALREADY TAKEN BY CUSTOMER: COMPLETE DISINFECTION OF LAB. CHANGE FILTERS IN HOOD. USES NEW CONSUMABLES. CHANCE PIPETTES. RUN THE TEST ON 4 DIFFERENT THERMOCYCLERS (2 MYGOPROS 2 QUANTS). DO A RUN IN ANOTHER LOCATION. ON THE SAME DAY, DID A RUN WITH THE OLD KIT OF OURS AND GENERATE VALID RESULTS. MANUFACTURER REACHED OUT TO CUSTOMER AND FIELD APPLICATIONS TEAM WERE ABLE TO WORK WITH CUSTOMER SITE TO PERFORM INVESTIGATIONAL TESTING ON 12TH MAY, USING NEW UNITS FROM THE SAME LOTS. INVESTIGATION CONCLUDED THAT CUSTOMER HAD CONTAMINATED KIT SOLUTIONS WITH POSITIVE CONTROL MATERIAL. NO FURTHER INVESTIGATION WAS PERFORMED. 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 STATES BATCH M220191 AND M2200215 MAYBE SEEMS TO BE CONTAMINATED. EVERY TESTED SAMPLE IS BECOMING POSITIVE. ACTIONS ALREADY TAKEN BY CUSTOMER: COMPLETE DISINFECTION OF LAB. CHANGE FILTERS IN HOOD. USES NEW CONSUMABLES. CHANGED PIPETTES. RUN THE TEST ON 4 DIFFERENT THERMOCYCLERS (2 MYGOPROS 2 QUANTS). DO A RUN IN ANOTHER LOCATION. ON THE SAME DAY, DID A RUN WITH THE OLD KIT OF OURS AND GENERATE VALID RESULTS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1857451 LUMIRADX RNA COV-2 STAR COMPLETE LUMIRADX RNA COV-2 STAR COMPLETE QJR LUMIRADX UK LTD. M2200215

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown