BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BIOCODE SARS-COV-2 ASSAY KIT

    MDR report key: 11694692 · Received April 20, 2021

    Report

    Report Number
    3007799234-2020-00002
    Event Type
    Malfunction
    Date Received
    April 20, 2021
    Date of Event
    September 30, 2020
    Report Date
    October 21, 2020
    Manufacturer
    APPLIED BIOCODE, INC
    Product Code
    QJR
    UDI-DI
    851034007080
    PMA / PMN Number
    EUA200433
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MD, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    END USER HAD RUN (B)(4) THAT WAS COVID FOR 6 PATIENT SAMPLES((B)(6)), ALONG WITH 88 OTHER PATIENT SAMPLES THAT WERE NEGATIVE. RESULTS WERE REPORTED TO THE NURSING HOME, BUT THE NURSING HOME DID NOT TREAT PATIENTS BASED UPON THE DETECTED RESULTS, THE PATIENTS WERE ALL ASYMPTOMATIC AND THE NURSING HOME USED THE RAPID RESULTS THAT WERE NEGATIVE. THE 6 POSITIVE SAMPLES REPEATED ON THE MDX-3000 AS NOT DETECTED. THE ORIGINAL AND REPEAT WERE SEPARATE EXTRACTIONS ON THE PERKIN ELMER "CHEMAGIC 360" EXTRACTION SYSTEM. INSTRUMENT (S/N(B)(4)) WAS USED FOR ORIGINAL AND REPEAT TESTING, PREVENTATIVE MAINTENANCE IS CURRENT AND NEXT DUE ON 2/25/2021. THERE DOES NOT APPEAR TO BE A PATTERN ON THE PLATE THAT WOULD INDICATE IN INSTRUMENT ISSUE. AFTER GOING LIVE WITH THE ASSAY ON (B)(6) 2020, THE END USER HAD 13 VALID RUNS WITH 996 SAMPLES AND ONLY 2 SAMPLES WITH COVID DETECTED, THE RUN RIGHT BEFORE THE RUN WITH 6 RUN HAS 59 "POOLED" SAMPLES. THE "POOLED" RUN WAS OVER HALF KNOWN POSITIVE SAMPLES THAT THE CUSTOMER TRYING TO DEVELOP A HOME BREW TEST THAT DOES NOT FOLLOW THE IFU FOR THE ABC SARS-COV-2 ASSAY. A PHONE CONVERSATION WITH THE END USER REVEALED THAT THEY WERE USING "UN-FILTERED" PIPETTE TIPS TO TRANSFER THE POOLED SAMPLES. WE SPECULATE THAT THE 6 SAMPLE DETECTED WERE CONTAMINATION FROM THE CUSTOMERS PREVIOUS RUN OF 'POOLED" SAMPLES, LIKELY CONTAMINATION FROM THE EXTRACTION OR SETUP AREA. CUSTOMER RAN 2 FULL PLATES OF JUST WATER SAMPLES AND SAW LOW LEVEL POSITIVES SIMILAR TO THE 6 PATIENT SAMPLES WITH A SINGLE TARGET BEING POSITIVE. REINFORCED TO THE CUSTOMER THAT THEY NEED TO USE GOOD ASEPTIC TECHNIQUE, WITH DISINFECTION OF THE EXTRACTION AND SETUP AREAS, AND ONLY USE FILTERED PIPETTE TIPS. AN ONSITE VISIT BY (B)(6) FIELD APPLICATION SCIENTIST ON (B)(6) 2020, WHO TRAINED THE END USER HOW TO USE THE INSTRUMENT REVELED A FEW THINGS. THERE WAS NO UNIDIRECTIONAL WORKFLOW, ALL STEPS BEING PERFORMED IN SAME HOOD(EXTRACTION SETUP, SAMPLE TRANSFER, ETC.) WITH THE SAMPLE SET OF PIPETTES BEING USED IN THE REAGENT SETUP(MASTER MIX, ETC). CORRECTED REPORT - UPDATED MANUFACTURER REPORT NUMBER SUBMITTED 04/21/2021

    Description of Event or Problem · 1

    CUSTOMER REPORTED THAT THEY HAD A RUN WITH 6 POSITIVE SAMPLES OUR OF 94 PATIENT SAMPLES. RESULTS WERE REPORTED TO THE NURSING HOME THAT ORDERED THE TEST. NURSING HOME DID A RAPID TEST IN HOUSE TO CONFIRM THE 6 POSITIVE, THE RESULTS WERE NEGATIVE WITH THE RAPID TEST. NURSING HOME THEN CONTACTED THE CUSTOMER USING THE MDX-3000, AND INFORMED OF THE RAPID RESULTS. THE CUSTOMER THEN RERAN THE 6 POSITIVE SAMPLES, PLUS 6 NEGATIVE SAMPLES FROM THE 94 SAMPLE RUN. THEY RAN THE 12 SAMPLES IN DUPLICATE, ONE SET BEING FRESH EXTRACTION FROM THE ORIGINAL SAMPLES TODAY, THE 2ND SET BEING THE EXTRACTED ELUATE FROM THE PREVIOUS DAY. ALL 6 POSITIVE SAMPLE CAME UP NEGATIVE IN DUPLICATE, 5 OF THE NEGATIVE SAMPLES WERE STILL NEGATIVE WITH 1 NEGATIVE SAMPLE COMING UP POSITIVE FOR THE NA TARGET.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    589418 BIOCODE SARS-COV-2 ASSAY KIT SARS-COV-2 ASSAY QJR APPLIED BIOCODE, INC COV-2.1 AK-07002 851034007080

    Patients

    Seq Age Sex Outcome Treatment
    1