BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ID NOW COVID-19

    MDR report key: 10107508 · Received June 1, 2020

    Report

    Report Number
    1221359-2020-00081
    Event Type
    Malfunction
    Date Received
    June 1, 2020
    Report Date
    February 19, 2021
    Manufacturer
    ABBOTT DIAGNOSTICS SCARBOROUGH, INC.
    Product Code
    QJR
    UDI-DI
    10811877011269
    PMA / PMN Number
    EUA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    TESTING WAS PERFORMED AT ABBOTT DIAGNOSTICS SCARBOROUGH, INC. ON RETAINED KIT LOT 1013833 WITH INTERNAL POSITIVE QUALITY CONTROL SAMPLES AND NEGATIVE QUALITY CONTROL SWABS. ALL TEST RESULTS WERE VALID AND PERFORMED AS EXPECTED. ADDITIONALLY, THE MANUFACTURING RECORDS AND QUALITY CONTROL RELEASE TESTING WAS REVIEWED FOR TEST KIT PART NUMBER 190-000 / LOT 1013833, TEST BASE PART NUMBER 190-430/ LOT 1013833. THE LOT MET THE REQUIRED RELEASE SPECIFICATIONS. THE REMAINDER OF THE INVESTIGATION REMAINS IN PROGRESS. A SUPPLEMENTAL REPORT WILL BE PROVIDED AFTER COMPLETION.

    Additional Manufacturer Narrative · 1

    TESTING WAS PERFORMED AT ABBOTT DIAGNOSTICS (B)(4), INC. ON RETAINED KIT LOT M119002 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 M119002 AND TEST BASE PART NUMBER 190-430 / LOT M119002 WERE REVIEWED. THIS LOT MET THE REQUIRED RELEASE SPECIFICATIONS. A REVIEW OF THE COMPLAINTS REPORTED AS FALSE NEGATIVE PATIENT RESULTS (CONFIRMED AND UNCONFIRMED, CONFLICTING RESULTS) RELATED TO KIT LOT M119002 SHOWED THAT THE COMPLAINT RATE IS (B)(4). THE EVIDENCE AVAILABLE DOES NOT INDICATE THAT THE PRODUCT IS PERFORMING OUTSIDE LABEL CLAIMS. 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

    A CUSTOMER REPORTED A FALSE NEGATIVE RESULT WITH THE ID NOW COVID-19 TEST. THE CUSTOMER ((B)(6)) REPORTED THAT A PATIENT GENERATED A NEGATIVE RESULT ON THE ID NOW COVID-19 ASSAY WITH A KIT-PROVIDED DIRECT NASAL SWAB SAMPLE. THE CUSTOMER REPORTED THEY DO NOT KNOW THE TESTING DATE AND TIME OF THE REPORTED FALSE NEGATIVE RESULT. THE CUSTOMER STATED THE TESTING WAS ONLY PERFORMED ONCE ON THE PATIENT. THE PATIENT WAS REPORTED TO HAVE TOLD THE CUSTOMER THAT THE "SWAB WAS NOT INSERTED HIGH ENOUGH" IN SAMPLING BOTH NOSTRILS. THE CUSTOMER REPORTED THAT THE PATIENT CONTACTED (B)(6) AND STATED THEY TESTED POSITIVE BY PCR (NOT OTHERWISE SPECIFIED) WITH A NASOPHARYNGEAL SAMPLE 24 HOURS AFTER NEGATIVE ID NOW COVID-19 RESULTS WERE OBTAINED. THE PATIENT WAS REPORTED TO HAVE HAD CONTACT WITH A COVID-19 POSITIVE PERSONNEL. PATIENT INFORMATION, INCLUDING SYMPTOMS, TREATMENT, IMPACT AND OUTCOME WERE UNKNOWN. ATTEMPTS TO OBTAIN FURTHER INFORMATION WERE NOT SUCCESSFUL. THE ID NOW COVID-19 PRODUCT INSERT INDICATES THAT NEGATIVE RESULTS DO NOT PRECLUDE SARS-COV-2 INFECTION AND SHOULD NOT BE USED AS THE SOLE BASIS FOR PATIENT MANAGEMENT DECISIONS. NEGATIVE RESULTS MUST BE COMBINED WITH CLINICAL OBSERVATIONS, PATIENT HISTORY, AND EPIDEMIOLOGICAL INFORMATION. ADDITIONALLY, THE ID NOW COVID-19 PRODUCT INSERT INCLUDES A LIMITATION THAT FALSE NEGATIVE RESULTS MAY OCCUR IF A SPECIMEN IS IMPROPERLY COLLECTED, TRANSPORTED OR HANDLED. FALSE NEGATIVE RESULTS MAY ALSO OCCUR IF AMPLIFICATION INHIBITORS ARE PRESENT IN THE SPECIMEN OR IF INADEQUATE LEVELS OF VIRUSES ARE PRESENT IN THE SPECIMEN. DUE TO THE RISK OF A POTENTIAL FALSE NEGATIVE RESULT LEADING TO NO OR DELAYED TREATMENT, THIS EVENT SHALL BE CONSIDERED REPORTABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    571195 ID NOW COVID-19 MOLECULAR IVD FOR ID NOW COVID-19 QJR ABBOTT DIAGNOSTICS SCARBOROUGH, INC. M119002 10811877011269

    Patients

    Seq Age Sex Outcome Treatment
    1