BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ID NOW COVID 19 ASSAY

    MDR report key: 12580498 · Received October 5, 2021

    Report

    Report Number
    1221359-2021-03012
    Event Type
    Malfunction
    Date Received
    October 5, 2021
    Date of Event
    January 13, 2021
    Report Date
    December 14, 2021
    Manufacturer
    ABBOTT DIAGNOSTICS SCARBOROUGH, INC.
    Product Code
    QJR
    PMA / PMN Number
    EUA2000074
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    H10: THE REQUIRED INTAKE INFORMATION TO ENABLE FURTHER INVESTIGATION, SUCH AS THE KIT'S LOT NUMBER, WAS NOT PROVIDED AND AN INVESTIGATION WAS NOT ABLE TO BE PERFORMED. NOTWITHSTANDING, A REVIEW OF COMPLAINTS' TREND REVEALS THAT ALL LOTS WITHIN EXPIRY DATING ARE PERFORMING ACCORDING TO THE STATEMENTS MADE IN THE PACKAGE INSERT. IN CONCLUSION, ABBOTT DIAGNOSTICS SCARBOROUGH WAS UNABLE TO DETERMINE THE EXACT ROOT CAUSE OF THE REPORTED ISSUES AS NO INFORMATION WAS PROVIDED FOR INVESTIGATION. REFERENCE MFR. REPORTS: 1221359-2021-02620, 1221359-2021-02987, 1221359-2021-02988, 1221359-2021-02989, 1221359- 2021-02990, 1221359-2021-02991, 1221359-2021-02992, 1221359-2021-02993, 1221359-2021-02994, 1221359-2021-02995, 1221359-2021-02996, 1221359-2021-02997, 1221359-2021-02998, 1221359-2021-02999, 1221359-2021-03000, 1221359- 2021-03001, 1221359-2021-03002, 1221359-2021-03003, 1221359-2021-03004, 1221359-2021-03005, 1221359-2021-03006, 1221359-2021-03007, 1221359-2021-03008, 1221359-2021-03009, 1221359-2021-03010, 1221359-2021-03011, 1221359- 2021-03013, 1221359-2021-03014, 1221359-2021-03015, 1221359-2021-03016, 1221359-2021-03017, 1221359-2021-03018, 1221359-2021-03019, 1221359-2021-03020, 1221359-2021-03021, 1221359-2021-03022, 1221359-2021-03023, 1221359- 2021-03024, 1221359-2021-03025, 1221359-2021-03026, 1221359-2021-03027, 1221359-2021-03028, 1221359-2021-03029, 1221359-2021-03030, 1221359-2021-03031, 1221359-2021-03032, 1221359-2021-03033, 1221359-2021-03034, 1221359-2021-03035, 1221359-2021-03036, 1221359-2021-03037, 1221359-2021-03038, 1221359-2021-03039, 1221359-2021-03040, 1221359-2021-03041, 1221359-2021-03042, 1221359-2021-03043, 1221359-2021-03044, 1221359-2021-03045, 1221359-2021-03046, 1221359-2021-03047, 1221359-2021-03048, 1221359-2021-03049, 1221359-2021-03050, 1221359-2021-03051, 1221359-2021-03052, 1221359-2021-03053, 1221359-2021-03054, 1221359-2021-03055, 1221359-2021-03056, 1221359-2021-03057, 1221359-2021-03058, 1221359-2021-03059, 1221359-2021-03060, 1221359-2021-03061, 1221359-2021-03062, AND 1221359-2021-03063.

    Additional Manufacturer Narrative · 0

    PT ID: (B)(6). THE INVESTIGATION IS STILL IN PROGRESS. A SUPPLEMENTAL REPORT WILL BE PROVIDED AFTER COMPLETION. REFERENCE MFR. REPORTS: 1221359-2021-02620, 1221359-2021-02987, 1221359-2021-02988, 1221359-2021-02989, 1221359-2021-02990, 1221359-2021-02991, 1221359-2021-02992, 1221359-2021-02993, 1221359-2021-02994, 1221359-2021-02995, 1221359-2021-02996, 1221359-2021-02997, 1221359-2021-02998, 1221359-2021-02999, 1221359-2021-03000, 1221359-2021-03001, 1221359-2021-03002, 1221359-2021-03003, 1221359-2021-03004, 1221359-2021-03005, 1221359-2021-03006, 1221359-2021-03007, 1221359-2021-03008, 1221359-2021-03009, 1221359-2021-03010, 1221359-2021-03011, 1221359-2021-03013, 1221359-2021-03014, 1221359-2021-03015, 1221359-2021-03016, 1221359-2021-03017, 1221359-2021-03018, 1221359-2021-03019, 1221359-2021-03020, 1221359-2021-03021, 1221359-2021-03022, 1221359-2021-03023, 1221359-2021-03024, 1221359-2021-03025, 1221359-2021-03026, 1221359-2021-03027, 1221359-2021-03028, 1221359-2021-03029, 1221359-2021-03030, 1221359-2021-03031, 1221359-2021-03032, 1221359-2021-03033, 1221359-2021-03034, 1221359-2021-03035, 1221359-2021-03036, 1221359-2021-03037, 1221359-2021-03038, 1221359-2021-03039, 1221359-2021-03040, 1221359-2021-03041, 1221359-2021-03042, 1221359-2021-03043, 1221359-2021-03044, 1221359-2021-03045, 1221359-2021-03046, 1221359-2021-03047, 1221359-2021-03048, 1221359-2021-03049, 1221359-2021-03050, 1221359-2021-03051, 1221359-2021-03052, 1221359-2021-03053, 1221359-2021-03054, 1221359-2021-03055, 1221359-2021-03056, 1221359-2021-03057, 1221359-2021-03058, 1221359-2021-03059, 1221359-2021-03060, 1221359-2021-03061, 1221359-2021-03062, AND 1221359-2021-03063.

    Description of Event or Problem · 0

    THE CUSTOMER REPORTED 79 FALSE POSITIVE RESULTS WITH THE ID NOW COVID-19 ASSAY FOR 79 PATIENTS PERFORMED ACROSS A RANGE OF DATES. THIS MFR. REPORT ADDRESSES PATIENT 27 OF 79. THE CUSTOMER REPORTED A FALSE POSITIVE RESULT WITH THE ID NOW COVID-19 ASSAY PERFORMED ON (B)(6) 2021 ON A NASOPHARYNGEAL SWAB. PCR CONFIRMATION TESTING GENERATED A NEGATIVE RESULT.(CT VALUE >45). NO ADDITIONAL PATIENT INFORMATION, INCLUDING TREATMENT AND OUTCOME, WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1473365 ID NOW COVID 19 ASSAY MOLECULAR IVD FOR ID NOW COVID-19 QJR ABBOTT DIAGNOSTICS SCARBOROUGH, INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 61 YR Female