BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ID NOW COVID-19

    MDR report key: 10868436 · Received November 19, 2020

    Report

    Report Number
    1221359-2020-00388
    Event Type
    Injury
    Date Received
    November 19, 2020
    Date of Event
    October 25, 2020
    Report Date
    December 31, 2020
    Manufacturer
    ABBOTT DIAGNOSTICS SCARBOROUGH INC.
    Product Code
    QJR
    UDI-DI
    10811877011269
    PMA / PMN Number
    EUA2000074
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    HI, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    TESTING WAS PERFORMED AT ABBOTT DIAGNOSTICS SCARBOROUGH, INC. ON RETAINED KIT LOT M126916 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 M126916 AND TEST BASE PART NUMBER 190-430 / LOT M126916 WERE REVIEWED. THIS LOT MET THE REQUIRED RELEASE SPECIFICATIONS. A REVIEW OF THE COMPLAINTS REPORTED AS FALSE POSITIVE PATIENT RESULTS (CONFIRMED AND UNCONFIRMED, CONFLICTING RESULTS) RELATED TO KIT LOT M126916 SHOWED THAT THE COMPLAINT RATE IS 0.004%. ABBOTT DIAGNOSTICS SCARBOROUGH, INC. WAS UNABLE TO DETERMINE THE EXACT ROOT CAUSE OF THE REPORTED ISSUE; HOWEVER, IT COULD POSSIBLY BE RELATED TO THE SPECIFIC PATIENT SAMPLES. 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. PLEASE SEE RELATED MFR REPORT #S: 1221359-2020-00387.

    Additional Manufacturer Narrative · 1

    THE INVESTIGATION IS STILL IN PROCESS. A SUPPLEMENTAL REPORT WILL BE SUBMITTED AFTER COMPLETION. PLEASE SEE RELATED MFR REPORT # 1221359-2020-00387.

    Description of Event or Problem · 1

    A CUSTOMER REPORTED FALSE POSITIVE / CONFLICTING RESULTS INVOLVING TWO (2) PATIENTS WITH THE ID NOW COVID-19 ASSAY. THIS REPORT REPRESENTS TWO (2) OF TWO (2). THE CUSTOMER REPORTED FALSE POSITIVE / CONFLICTING RESULTS ON A DIRECT NASOPHARYNGEAL SWAB (NOT PROVIDED IN THE KIT) WITH THE ID NOW COVID-19 ASSAY PERFORMED ON (B)(6) 2020. REPEAT TESTING WITH A NEW NASOPHARYNGEAL SAMPLE PERFORMED ON (B)(6) 2020 GENERATED A NEGATIVE RESULT. CONFIRMATION TESTING FROM A NASOPHARYNGEAL SPECIMEN WITH PCR (NOT SPECIFIED) GENERATED A NEGATIVE RESULT (CT VALUE = 0). THE CUSTOMER REPORTED THE PATIENT WAS SYMPTOMATIC. THE CUSTOMER ALSO REPORTED THAT THE PATIENT WAS ADMITTED TO A HOSPITAL ON (B)(6) 2020 FOR 4 DAYS DUE TO THE POSITIVE RESULT. THE CUSTOMER REPORTED THE PATIENT WAS DIAGNOSED WITH PNEUMONIA AND TREATED APPROPRIATELY. NO ADDITIONAL PATIENT INFORMATION WAS PROVIDED. THE CUSTOMER CONFIRMED THERE WAS NO DEATH OR SERIOUS INJURY BASED ON THE TEST RESULTS. 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 AS IT RESULTED IN HOSPITALIZATION OF THE PATIENT. ADDITIONALLY, UNEXPLAINED CONFLICTING RESULTS SHALL BE REPORTED AS A MALFUNCTION, AS IT IS UNKNOWN WHICH RESULT IS CORRECT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1336594 ID NOW COVID-19 MOLECULAR IVD FOR ID NOW COVID-19 QJR ABBOTT DIAGNOSTICS SCARBOROUGH INC. M126916 10811877011269

    Patients

    Seq Age Sex Outcome Treatment
    1 76 YR Hospitalization