BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ID NOW COVID-19 ASSAY

    MDR report key: 11389408 · Received February 26, 2021

    Report

    Report Number
    1221359-2021-00551
    Event Type
    Injury
    Date Received
    February 26, 2021
    Date of Event
    January 27, 2021
    Report Date
    April 22, 2021
    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
    MO, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    ADDITIONAL INFORMATION: (B)(4). 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 SAMPLE.

    Additional Manufacturer Narrative · 1

    TESTING WAS PERFORMED AT ABBOTT DIAGNOSTICS (B)(4), INC. ON RETAINED KIT LOT M137396 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: M137396, TEST BASE PART NUMBER 190-430/LOT:M137396. THE LOT MET THE REQUIRED RELEASE SPECIFICATIONS. THE REMAINDER OF THE INVESTIGATION REMAINS IN PROGRESS. A SUPPLEMENTAL REPORT WILL BE PROVIDED AFTER COMPLETION.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED A FALSE POSITIVE RESULT WITH THE ID NOW COVID-19 ASSAY PERFORMED ON (B)(6) 2021 ON A DIRECT TESTED NASOPHARYNGEAL PURITAN MEDICAL PRODUCTS HYDRAFLOCK SWAB. REPEAT TESTING WAS NOT PERFORMED. CONFIRMATION TESTING ON A NASOPHARYNGEAL SWAB WITH CEPHEID PLATFORM GENERATED NEGATIVE RESULTS (CT VALUES NOT PROVIDED). PER CUSTOMER, THE PATIENT IS A (B)(6) YEAR OLD MALE, WITH A HISTORY OF CHRONIC OBSTRUCTIVE PULMONARY DISEASE AND HE IS ON CHRONIC OXYGEN, HYPERTENSION ( HTN ), HYPERSENTIVITY LUNG DISEASE ( HLD), DIABETES MELLITUS TYPE 2 ( DM), CORONARY ARTEY DISEASE ( CAD), CORONARY ARTEY BYPASS GRAFT SURGERY ( CABG) , CEREBROVASCULAR ACCIDENT ( CVA) AND TRANSIENT ISCHAEMIC ATTACK. PATIENT PRESENTED TO THE EMERGENCY ROOM ( ED) VIA EMERGENCY MEDICAL SERVICES ( EMS) FOR EVALUATION FOR HIS SHORTNESS OF BREATH ( SOB). THE CUSTOMER STATED THE PATIENT WAS SYMPTOMATIC AND RECEIVED ENOXAPARIN 40 MG Q12H, DOXYCYCLINE 100 MG Q12H, DEXTROSE 50% SOLUTION IV PRN, CLOPIDOGREL 75 MG NIGHTLY, CARVEDILOL 25 MG BID W/MEALS, BACLOFEN 10 MG TID, ARIPIPRAZOLE 5 MG NIGHTLY, AMITRIPTYLINE 50 MG NIGHTLY, ALUM-MAG HYDROXINE-SIMETH 20 ML Q4HR PRN, ALBUTEROL 2.5 MG/0.5 ML NEBULIZER 2.5 MG Q4HR PRN. TELEMETRY MONITORING, DAILY WEIGHTS, VENTILATION/NON-INVASIVE, CONTINUOUS PULSE OXIMETRY, INTAKE AND OUTAKE, ASPIRATION PRECAUTIONS, MAINTAIN IV STATUS. ADDITIONALLY, THE PATIENT WAS ADMITTED TO THE HOSPITAL AND ISOLATION WAS INITIATED. POSITIVE RESULTS ARE INDICATIVE OF THE PRESENCE OF SARS-COV-2 RNA; CLINICAL CORRELATION WITH PATIENT HISTORY AND OTHER DIAGNOSTIC INFORMATION IS NECESSARY TO DETERMINE PATIENT INFECTION STATUS. POSITIVE RESULTS DO NOT RULE OUT BACTERIAL INFECTION OR CO-INFECTION WITH OTHER VIRUSES. DUE TO THE RISK OF A FALSE POSITIVE RESULT LEADING TO POSSIBLE EXPOSURE TO COVID-19 THROUGH THE QUARANTINE OF THE FALSE POSITIVE PATIENT WITH TRUE POSITIVE PATIENT(S), DELAYED EMERGENCY TREATMENT AND/OR INAPPROPRIATE TREATMENT WITH ANTIVIRAL THERAPY, THE INCIDENT SHALL BE CONSIDERED REPORTABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    280215 ID NOW COVID-19 ASSAY MOLECULAR IVD FOR ID NOW COVID-19 QJR ABBOTT DIAGNOSTICS SCARBOROUGH, INC. M137396 10811877011269

    Patients

    Seq Age Sex Outcome Treatment
    1 47 YR Other