BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ID NOW COVID-19 ASSAY

    MDR report key: 11817135 · Received May 13, 2021

    Report

    Report Number
    1221359-2021-01456
    Event Type
    Malfunction
    Date Received
    May 13, 2021
    Date of Event
    April 8, 2021
    Report Date
    July 1, 2021
    Manufacturer
    ABBOTT DIAGNOSTICS SCARBOROUGH, INC.
    Product Code
    QJR
    UDI-DI
    10811877011320
    PMA / PMN Number
    EUA2000074
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    HK
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    THIS SUPPLEMENTAL REPORT IS BEING SUBMITTED TO REPORT THE INVESTIGATION CONCLUSION AND ADDITIONAL INFORMATION. THE BELOW INFORMATION WAS REPORTED UNDER RELATED MFR. REPORT # 1221359-2021-01477 BUT BELONGS TO 1221359-2021-01456. INVESTIGATION: TESTING WAS PERFORMED AT ABBOTT DIAGNOSTICS SCARBOROUGH, INC. ON RETAINED KIT LOT 1013538 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 191-000/ LOT 1013538, TEST BASE PART NUMBER 190-430 /LOT 1013538. THE LOT MET THE REQUIRED RELEASE SPECIFICATIONS. A REVIEW OF THE COMPLAINTS REPORTED AS FALSE POSITIVE PATIENT RESULTS (CONFIRMED AND UNCONFIRMED, CONFLICTING RESULTS) RELATED TO KIT LOT 1013538 SHOWED THAT THE COMPLAINT RATE IS 0.0004%. IN CONCLUSION, ABBOTT DIAGNOSTICS SCARBOROUGH WAS UNABLE TO DETERMINE THE EXACT ROOT CAUSE OF THE REPORTED ISSUE; HOWEVER BASED ON THE INFORMATION PROVIDED BY THE CUSTOMER AND THE IMAGES PROVIDED FOR REVIEW IT APPEARED TO BE RELATED TO MANUFACTURING EXECUTION.

    Additional Manufacturer Narrative · 1

    THE INVESTIGATION IS STILL IN PROGRESS. A SUPPLEMENTAL REPORT WILL BE PROVIDED AFTER COMPLETION. PLEASE REFERENCE MFR. REPORT # 1221359-2021-01477.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED TWO (2) FALSE POSITIVE RESULTS WITH THE ID NOW COVID-19 ASSAY FOR MULTIPLE PATIENTS. THIS MFR. REPORT ADDRESSES PATIENT 1 OF 2. THE CUSTOMER REPORTED A FALSE POSITIVE RESULTS WITH THE ID NOW COVID-19 ASSAY PERFORMED ON (B)(6) 2021 ON A TESTED NASAL SWAB . THE NASAL SWAB WAS USED TO SWAB BOTH NOSTRILS. THERE WAS NO BLOOD VISIBLE ON THE SWAB. THE PATIENT WAS A CHILD WITH FLU-LIKE SYMPTOMS. ONCE THE USER OBTAINED A POSITIVE RESULT FROM ID NOW, THEY IMMEDIATELY INFORMED THE DEPARTMENT OF HEALTH AND REFERRED THE CASE TO GOVERNMENT HOSPITAL. REPEAT TESTING WAS NOT PERFORMED. THE CUSTOMER REPORTED THIS PATIENT WAS THEN SENT TO A GOVERNMENT FACILITY FOR FURTHER TESTING AND ISOLATION. ON THE SAME DAY (B)(6) 2021 AT NIGHT, A NASOPHARYNGEAL (NPS) SPECIMEN AND BLOOD SAMPLE WERE COLLECTED FOR RT-PCR TEST AND ANTI-BODIES TEST. BOTH TEST RESULTS WERE NEGATIVE. THE CUSTOMER REPORTED ANOTHER SET OF SPECIMENS WERE COLLECTED ON (B)(6) 2021 AT NIGHT TIME FOR REPEAT TESTING, AGAIN BOTH TEST RESULTS REMAIN NEGATIVE. THE PATIENT WAS DISCHARGED ON (B)(6) 2021 MORNING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    718289 ID NOW COVID-19 ASSAY MOLECULAR IVD FOR ID NOW COVID-19 QJR ABBOTT DIAGNOSTICS SCARBOROUGH, INC. 1013538 10811877011320

    Patients

    Seq Age Sex Outcome Treatment
    1 3 YR Congenital Anomaly