BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ID NOW COVID-19 ASSAY

    MDR report key: 15564284 · Received October 7, 2022

    Report

    Report Number
    1221359-2022-05117
    Event Type
    Malfunction
    Date Received
    October 7, 2022
    Date of Event
    September 28, 2022
    Report Date
    January 11, 2023
    Manufacturer
    ABBOTT DIAGNOSTICS SCARBOROUGH, INC.
    Product Code
    QJR
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    THE CUSTOMER PROVIDED THE LOT NUMBERS BUT WAS NOT ABLE TO IDENTIFY WHICH LOT WENT WITH WHICH PATIENT. THE LOT INFORMATION HAS BEEN ADDED BELOW. PRODUCT LOT DETAILS: LOT NUMBER: M213554, UDI: (B)(4). EXPIRATION DATE: 05/11/2023, MANUFACTURED DATE: 08/13/2022. LOT NUMBER: M214196, UDI: (B)(4), EXPIRATION DATE: 05/16/2023, MANUFACTURED DATE:08/18/2022. LOT NUMBER: M211606, UDI: (B)(4), EXPIRATION DATE: 05/05/2023. THE INVESTIGATION IS STILL IN PROGRESS. A SUPPLEMENTAL REPORT WILL BE PROVIDED AFTER COMPLETION. PLEASE REFERENCE ALL RELATED MFR. REPORT NUMBERS: 1221359-2022-05117 THROUGH 1221359-2022-05123.

    Additional Manufacturer Narrative · 0

    INVESTIGATION REPORT: TESTING WAS PERFORMED AT ABBOTT DIAGNOSTICS SCARBOROUGH, INC. ON RETAINED KIT LOT M213554, M214196, M211606 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 KIT PART NUMBER 190-000J / LOT M213554 / LOT M214196 / M211606 AND TEST BASE PART NUMBER 190-430 / LOT M213554 / LOT M214196 / M211606. THE LOTS MET THE REQUIRED RELEASE SPECIFICATIONS. FOR THE FOLLOWING LOT NUMBERS, THE CURRENT OVERALL PERCENTAGE OF FALSE POSITIVE PATIENT RESULTS (CONFIRMED, UNCONFIRMED, AND CONFLICTING), BASED ON THE TOTAL NUMBER OF DEVICES SOLD AND THE EVIDENCE AVAILABLE, INDICATES THEY ARE PERFORMING AS EXPECTED: M213554= 0.002%. M214196= 0.002%. M211606= 0.002%. ABBOTT DIAGNOSTICS SCARBOROUGH WAS UNABLE TO DETERMINE THE EXACT ROOT CAUSE OF THE REPORTED ISSUE AS THE LOGFILES WERE NOT RETURNED FOR ANALYSIS TO IDENTIFY THE ROOT CAUSE OF THE FALSE POSITIVE RESULTS.

    Description of Event or Problem · 0

    THE CUSTOMER REPORTED 7 FALSE POSITIVE RESULTS WITH THE ID NOW COVID-19 ASSAY PERFORMED BETWEEN (B)(6) 2022 USING LOT NUMBERS M211606, M213554, M214196. THIS REPORT ADDRESSES PATIENT RESULTS 1 OF 7. THE CUSTOMER REPORTED A FALSE POSITIVE RESULT WITH THE ID NOW COVID-19 ASSAY PERFORMED ON (B)(6) 2022 ON A DIRECT TESTED NASOPHARYNGEAL SWAB THAT GENERATED A POSITIVE RESULT. PCR TESTING WAS NOT PERFORMED, HOWEVER IT IS ALLEGED AS A FALSE POSITIVE BECAUSE THE PATIENT IS ASYMPTOMATIC. THE CUSTOMER CONFIRMED THERE WAS NO PATIENT HARM DUE TO THE TEST RESULTS. ADDITIONALLY, THE CUSTOMER CONFIRMED THERE WAS NO DELAY OR IMPACT IN THE PATIENT TREATMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2554929 ID NOW COVID-19 ASSAY REAGENTS, 2019-NOVEL CORONAVIRUS NUCLEIC ACID QJR ABBOTT DIAGNOSTICS SCARBOROUGH, INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown