BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ID NOW COVID-19

    MDR report key: 10748018 · Received October 28, 2020

    Report

    Report Number
    1221359-2020-00324
    Event Type
    Malfunction
    Date Received
    October 28, 2020
    Date of Event
    October 2, 2020
    Report Date
    November 20, 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
    WV, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    ADDITIONAL INFORMATION PROVIDED BY THE CUSTOMER ON 28 OCTOBER 2020 IDENTIFIED THE DIAGNOSTIC METHODOLOGY AND RESULTS OF THE CONFIRMATORY TESTING. THE CUSTOMER STATED SHE BELIEVED THE NASAL SAMPLE SENT TO LABCORP WAS TESTED WITH PCR. THE RESULTS WERE NEGATIVE.

    Additional Manufacturer Narrative · 1

    TESTING WAS PERFORMED AT ABBOTT DIAGNOSTICS (B)(4), INC. ON RETAINED KIT LOT 1002069 WITH INTERNAL POSITIVE QUALITY CONTROL SAMPLES AND NEGATIVE QUALITY CONTROL SWABS. ALL TEST RESULTS WERE VALID AND PERFORMED AS EXPECTED. ADDITIONALLY, THE MANUFACTURING BATCH RECORDS AND QUALITY CONTROL RELEASE TESTING FOR KIT PART NUMBER 190-000 / LOT 1002069 AND TEST BASE PART NUMBER 190-430 / LOT 1002069 WERE REVIEWED. THIS LOT MET THE REQUIRED RELEASE SPECIFICATIONS. A REVIEW OF THE COMPLAINTS REPORTED AS FALSE POSITIVE AND AS FALSE NEGATIVE PATIENT RESULTS (CONFIRMED AND UNCONFIRMED, CONFLICTING RESULTS) RELATED TO KIT LOT 1002069 SHOWED THAT THE COMPLAINT RATE ARE (B)(4) AND (B)(4), RESPECTIVELY. 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 CONFLICTING RESULTS WITH THE ID NOW COVID-19 ASSAY. THE CUSTOMER REPORTED A POSITIVE RESULT ON A DIRECT NASAL SWAB WITH THE ID NOW COVID-19 ASSAY PERFORMED (B)(6) 2020 AT 11:39. ONE NOSTRIL WAS SWABBED, NOT BOTH AS INSTRUCTED IN THE PRODUCT INSERT. THREE REPEAT TESTS WERE PERFORMED (B)(6) 2020 AT 13:32 (NEW SWAB), 13:46 (RETEST OF SAMPLE ONE), AND 14:46 (NEW SWAB) GENERATED NEGATIVE RESULTS. A KITTED SWAB WAS USED TO SWAB BOTH NOSTRILS. A NEW SAMPLE WAS COLLECTED AND SENT FOR CONFIRMATION TESTING (NOT FURTHER SPECIFIED; RESULTS NOT PROVIDED). THERE WAS NO DEATH OR SERIOUS INJURY BASED ON ID NOW COVID-19 RESULT. THE PATIENT'S TREATMENT WAS NOT IMPACTED OR DELAYED. HOWEVER, THE CUSTOMER STATED THE WHOLE NURSING FACILITY NEEDED TO BE TESTED. THE CUSTOMER WAS NOT CERTAIN IF THE PATIENT WAS SYMPTOMATIC. THE CUSTOMER STATED THE PATIENT WAS AWAY FROM THE NURSING HOME AND NEEDED TESTING TO RE-ENTER THE NURSING HOME. NO ADDITIONAL PATIENT INFORMATION, INCLUDING TREATMENT AND OUTCOME, WAS PROVIDED. 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. NEGATIVE RESULTS SHOULD BE TREATED AS PRESUMPTIVE AND, IF INCONSISTENT WITH CLINICAL SIGNS AND SYMPTOMS OR NECESSARY FOR PATIENT MANAGEMENT, SHOULD BE TESTED WITH DIFFERENT AUTHORIZED OR CLEARED MOLECULAR TESTS. NEGATIVE RESULTS DO NOT PRECLUDE SARS-COV-2 INFECTION AND SHOULD NOT BE USED AS THE SOLE BASIS FOR PATIENT MANAGEMENT DECISIONS. NEGATIVE RESULTS SHOULD BE CONSIDERED IN THE CONTEXT OF A PATIENT'S RECENT EXPOSURES, HISTORY AND THE PRESENCE OF CLINICAL SIGNS AND SYMPTOMS CONSISTENT WITH COVID-19. UNEXPLAINED CONFLICTING RESULTS SHALL BE REPORTED AS IT IS UNKNOWN WHICH RESULT IS CORRECT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1210727 ID NOW COVID-19 MOLECULAR IVD FOR ID NOW COVID-19 QJR ABBOTT DIAGNOSTICS SCARBOROUGH, INC. 1002069 10811877011269

    Patients

    Seq Age Sex Outcome Treatment
    1 66 YR