BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ID NOW COVID-19

    MDR report key: 10825964 · Received November 11, 2020

    Report

    Report Number
    1221359-2020-00385
    Event Type
    Malfunction
    Date Received
    November 11, 2020
    Date of Event
    October 3, 2020
    Report Date
    November 11, 2020
    Manufacturer
    ABBOTT DIAGNOSTICS SCARBOROUGH, INC.
    Product Code
    QJR
    UDI-DI
    10811877011269
    PMA / PMN Number
    EUA2000074
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TN, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    TESTING WAS PERFORMED AT ABBOTT DIAGNOSTICS (B)(4), INC. ON RETAINED KIT LOT M123674 WITH INTERNAL POSITIVE QUALITY CONTROL SAMPLES AND NEGATIVE QUALITY CONTROL SWABS. ALL TEST RESULTS WERE VALID, AND PERFORMED AS EXPECTED. THE MANUFACTURING RECORDS AND QUALITY CONTROL RELEASE TESTING WAS REVIEWED FOR KIT PART NUMBER 190-000 / LOT M123674 AND TEST BASE PART NUMBER 190-430 / LOT M123674 AND MET SPECIFICATIONS. A REVIEW OF THE COMPLAINTS REPORTED AS FALSE NEGATIVE PATIENT RESULTS (CONFIRMED AND UNCONFIRMED, CONFLICTING RESULTS) RELATED TO KIT LOT M123674 SHOWED THAT THE COMPLAINT RATE IS (B)(4). ABBOTT DIAGNOSTICS (B)(4), INC. WAS UNABLE TO DETERMINE THE EXACT ROOT CAUSE OF THE REPORTED ISSUE. THE AVAILABLE EVIDENCE SUGGESTS THAT THIS DEVICE LOT IS PERFORMING WITHIN THE STATEMENTS MADE WITHIN PACKAGE INSERT RELATED TO % TEST AGREEMENT WITH THE EXPECTED RESULTS BY SAMPLE CONCENTRATION.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED FOUR (4) FALSE POSITIVE RESULTS WITH THE ID NOW COVID-19 ASSAY. THIS REPORT REPRESENTS PATIENT FOUR (4) OF FOUR (4). THE CUSTOMER REPORTED A FALSE POSITIVE RESULT ON A DIRECT TESTED TYPENEX NASOPHARYNGEAL (NP) SWAB WITH THE ID NOW COVID-19 ASSAY PERFORMED ON (B)(6) 2020. ON (B)(6) 2020, CONFIRMATION TESTING ON A NP SAMPLE WITH PCR (NOT OTHERWISE SPECIFIED) GENERATED NEGATIVE RESULTS. REPEAT TESTING ON A NP SWAB WITH THE ID NOW COVID-19 ASSAY PERFORMED ON (B)(6) 2020, GENERATED NEGATIVE RESULTS. THE CUSTOMER CONFIRMED THERE WAS NO DEATH, OR SERIOUS INJURY. IT WAS UNKNOWN IF THE PATIENT WAS SYMPTOMATIC. THE PATIENT WAS IN THE EMERGENCY DEPARTMENT, ADMITTED, AND ISOLATED IN THE ICU. TREATMENTS OR PATIENT IMPACT WAS UNKNOWN. THE CUSTOMER TOOK ENVIRONMENTAL SWAB TESTING OF THE INSTRUMENT, LAB BENCH AREA AND THE PLEXIGLASS SHIELD THEY USE TO COVER THE ID NOW INSTRUMENT. ALL THREE TESTED POSITIVE. THE CUSTOMER CLEANED WITH THE STERI-WIPE ISOPROPYL AND RECOLLECTED SAME ENVIRONMENTAL SAMPLES. ALL THREE WERE STILL POSITIVE AGAIN. THE CUSTOMER CLEANED AGAIN USING STERI-WIPE 0.63% HYPOCHLORITE (10% BLEACH EQUIVALENT 4 MINUTE RESIDENCE TIME TREATMENT). THE BENCH AND PLEXIGLASS TESTED NEGATIVE, BUT INSTRUMENT WAS STILL POSITIVE. THE CUSTOMER DID A THIRD ROUND OF CLEANING WITH STERI-WIPE ISOPROPYL, AND RE-COLLECTED SAME 3 ENVIRONMENTAL SAMPLES. ALL THREE AGAIN TESTED POSITIVE. THE CUSTOMER DISCONTINUED USE WITH THAT ID NOW MACHINE. THE CUSTOMER COLLECTED ENVIRONMENTAL SAMPLES, AND TESTED THEIR OTHER ID NOW INSTRUMENTS, AND HAVE NOT HAD ANY ISSUES. POSITIVE RESULTS ARE INDICATIVE OF THE PRESENCE OF SARS-COV-2 RNA. PER THE ID NOW COVID-19 PRODUCT INSERT, PRECAUTIONS INCLUDE: DUE TO THE HIGH SENSITIVITY OF THE ASSAYS RUN ON THE INSTRUMENT, CONTAMINATION OF THE WORK AREA WITH PREVIOUS POSITIVE SAMPLES MAY CAUSE FALSE POSITIVE RESULTS. HANDLE SAMPLES ACCORDING TO STANDARD LABORATORY PRACTICES. CLEAN INSTRUMENTS AND SURROUNDING SURFACES ACCORDING TO INSTRUCTIONS PROVIDED IN THE CLEANING SECTION OF THE INSTRUMENT USER MANUAL. REFER TO SECTION 1.6, MAINTENANCE & CLEANING, FOR FURTHER INFORMATION. THIS EVENT SHALL BE CONSIDERED REPORTABLE BECAUSE OF THE HIGH RISK SITUATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1289921 ID NOW COVID-19 MOLECULAR IVD FOR ID NOW COVID-19 QJR ABBOTT DIAGNOSTICS SCARBOROUGH, INC. M123674 10811877011269

    Patients

    Seq Age Sex Outcome Treatment
    1 21 YR