BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ID NOW COVID-19 ASSAY

    MDR report key: 12389498 · Received August 30, 2021

    Report

    Report Number
    1221359-2021-02411
    Event Type
    Malfunction
    Date Received
    August 30, 2021
    Report Date
    December 10, 2021
    Manufacturer
    ABBOTT DIAGNOSTICS SCARBOROUGH, INC.
    Product Code
    QJR
    UDI-DI
    10811877011269
    PMA / PMN Number
    EUA2000074
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    H10: TESTING WAS PERFORMED AT ABBOTT DIAGNOSTICS SCARBOROUGH, INC. ON RETAINED KIT LOT 1033145 WITH INTERNAL POSITIVE QUALITY CONTROL SAMPLES AND NEGATIVE QUALITY CONTROL SWABS. ALL TEST RESULTS WERE VALID AND PERFORMED AS EXPECTED. ADDITIONALLY, MANUFACTURING RECORDS AND QUALITY CONTROL RELEASE TESTING WAS REVIEWED FOR KIT PART NUMBER 190-000 / LOT 1033145. THE LOT MET THE REQUIRED RELEASE SPECIFICATIONS. A REVIEW OF THE COMPLAINTS REPORTED AS FALSE NEGATIVE PATIENT RESULTS (CONFIRMED AND UNCONFIRMED, CONFLICTING), RELATED TO KIT LOT 1033145 SHOWED THAT THE COMPLAINT RATE IS (B)(4). ABBOTT DIAGNOSTICS SCARBOROUGH, INC. WAS UNABLE TO DETERMINE THE EXACT ROOT CAUSE OF THE REPORTED ISSUE HOWEVER A POSSIBLE ASSIGNABLE ROOT CAUSE IS PATIENT SAMPLE INTERFERENCE.

    Additional Manufacturer Narrative · 1

    REFERENCE MFR. REPORT: 1221359-2021-02397, 1221359-2021- 02399, 1221359-2021-02409, 1221359-2021-02412. THE INVESTIGATION IS STILL IN PROGRESS. A SUPPLEMENTAL REPORT WILL BE PROVIDED AFTER COMPLETION.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED SEVEN FALSE NEGATIVE RESULTS WITH THE ID NOW COVID-19 ASSAY ON MULTIPLE LOT NUMBERS PERFORMED ON VARIOUS DATES. THIS MFR. REPORT ADDRESSES FOUR (4) OF FIVE (5). THE CUSTOMER REPORTED FALSE NEGATIVE RESULT ON THE ID NOW COVID-19 ASSAYS PERFORMED ON (B)(6) 2021 ON A NASAL SWAB. ADDITIONAL TESTING ON A NASOPHARYNGEAL (NP) IN VIRAL TRANSPORT MEDIA PERFORMED ON (B)(6) 2021 WITH BIOFIRE PLATFORM (RESULT DETECTED). NO ADDITIONAL PATIENT INFORMATION, INCLUDING SYMPTOMS, TREATMENT, IMPACT AND OUTCOME WAS NOT PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1286465 ID NOW COVID-19 ASSAY MOLECULAR IVD FOR ID NOW COVID-19 QJR ABBOTT DIAGNOSTICS SCARBOROUGH, INC. 1033145 10811877011269

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown