BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ID NOW COVID-19

    MDR report key: 10767140 · Received October 31, 2020

    Report

    Report Number
    1221359-2020-00356
    Event Type
    Malfunction
    Date Received
    October 31, 2020
    Date of Event
    September 24, 2020
    Report Date
    November 24, 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
    KS, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    ADDITIONAL INFORMATION: H10-TESTING WAS PERFORMED AT ABBOTT DIAGNOSTICS SCARBOROUGH, INC. ON RETAINED KIT LOT M120401 WITH INTERNAL POSITIVE QUALITY CONTROL SAMPLES AND NEGATIVE QUALITY CONTROL SWABS. ALL TEST RESULTS WERE VALID AND PERFORMED AS EXPECTED. THE REVIEW OF COMPLAINTS AGAINST THE KIT LOT FOR THE REPORTED ISSUE INDICATES THAT THE PRODUCT IS PERFORMING ACCORDING TO THE STATEMENTS CONTAINED IN THE PACKAGE INSERT AND A PRODUCT DEFICIENCY HAS NOT BEEN IDENTIFIED. ABBOTT DIAGNOSTICS SCARBOROUGH WAS UNABLE TO DETERMINE THE EXACT ROOT CAUSE OF THE REPORTED ISSUE; HOWEVER, IT COULD POSSIBLY BE RELATED TO THE SPECIFIC PATIENT SAMPLES. CORRECTED DATA: D4 H10- THE CUSTOMER REPORTED 3 FALSE NEGATIVE RESULTS WITH THE ID NOW COVID-19 ASSAY PERFORMED BETWEEN (B)(6) 2020 (07 OCTOBER 2020 INADVERTENTLY REPORTED ON INITIAL MDR).

    Additional Manufacturer Narrative · 1

    THE MANUFACTURING RECORDS AND QUALITY CONTROL RELEASE TESTING WAS REVIEWED FOR KIT PART NUMBER 190-000 / LOT M120401 AND TEST BASE PART NUMBER 190-430 / LOT M120401. NO FALSE NEGATIVE RESULTS WERE OBSERVED DURING QUALITY CONTROL RELEASE TESTING. A REVIEW OF THE COMPLAINTS REPORTED AS FALSE NEGATIVE PATIENT RESULTS (CONFIRMED AND UNCONFIRMED, CONFLICTING RESULTS) RELATED TO KIT LOT M120401 SHOWED THAT THE COMPLAINT RATE IS (B)(4). ADDITIONAL INFORMATION IS UNAVAILABLE AT THIS TIME.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED 3 FALSE NEGATIVE RESULTS WITH THE ID NOW COVID-19 ASSAY PERFORMED BETWEEN (B)(6) 2020 AND (B)(6) 2020. THIS REPORT REPRESENTS PATIENT ONE 1 OF 3. THE CUSTOMER REPORTED A FALSE NEGATIVE RESULT ON A DIRECT TESTED NASAL KITTED SWAB WITH THE ID NOW COVID- 19 ASSAY PERFORMED FROM (B)(6) 2020. THE NASAL SWAB WAS USED TO SWAB BOTH NOSTRILS PER THE PRODUCT INSERT INSTRUCTIONS. REPEAT TESTING WAS NOT PERFORMED. CONFIRMATION TESTING ON NASOPHARYNGEAL SWABS WITH QUEST PCR GENERATED POSITIVE RESULTS (CT VALUES NOT PROVIDED). THE CUSTOMER CONFIRMED THERE WAS NO DEATH OR SERIOUS INJURY BASED ON THE TEST RESULTS. THE CUSTOMER CONFIRMED THERE WAS NO DELAY OR IMPACT IN THE PATIENT'S TREATMENT. THE CUSTOMER STATED THAT THE PATIENT WAS SYMPTOMATIC. NO ADDITIONAL PATIENT INFORMATION, INCLUDING TREATMENT AND OUTCOME, WAS PROVIDED. 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. DUE TO THE RISK OF A FALSE NEGATIVE RESULT LEADING TO NO OR DELAYED TREATMENT, THE INCIDENT SHALL BE CONSIDERED REPORTABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1231979 ID NOW COVID-19 MOLECULAR IVD FOR ID NOW COVID-19 QJR ABBOTT DIAGNOSTICS SCARBOROUGH, INC. M120401 10811877011269

    Patients

    Seq Age Sex Outcome Treatment
    1 69 YR