BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ID NOW COVID-19 TEST KIT 24T JP

    MDR report key: 15999209 · Received December 16, 2022

    Report

    Report Number
    1221359-2022-10343
    Event Type
    Malfunction
    Date Received
    December 16, 2022
    Date of Event
    December 1, 2022
    Report Date
    March 10, 2023
    Manufacturer
    ABBOTT DIAGNOSTICS SCARBOROUGH, INC.
    Product Code
    QJR
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JP
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    DATE OF EVENT PROVIDED SECTION IN B3 IS AN APPROXIMATION, WAS NOT PROVIDED BY CONSUMER. THE REMAINDER OF THE INVESTIGATION REMAINS IN PROGRESS. A SUPPLEMENTAL REPORT WILL BE PROVIDED AFTER COMPLETION. H3 OTHER TEXT : DEVICE DISCARDED, SINGLE USE DEVICE.

    Additional Manufacturer Narrative · 0

    ADDITIONAL INFORMATION: D4 (EXPIRATION DATE) AND H4 (DEVICE MFG DATE). TESTING WAS PERFORMED IN DUPLICATE AT ABBOTT DIAGNOSTICS SCARBOROUGH, INC. ON RETAINED KIT LOT M213667 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 M213667 AND TEST BASE PART NUMBER 190-430 / LOT M213667. THE LOT MET THE REQUIRED RELEASE SPECIFICATIONS. THE REVIEW OF THE COMPLAINTS REPORTED AS FALSE POSITIVE PATIENT RESULTS (CONFIRMED, UNCONFIRMED AND CONFLICTING RESULTS) RELATED TO KIT LOT M213667 SHOWED THAT THE COMPLAINT RATE IS (B)(4). ABBOTT DIAGNOSTICS SCARBOROUGH, INC. WAS UNABLE TO DETERMINE THE EXACT ROOT CAUSE OF THE REPORTED ISSUE. H3 OTHER TEXT : DEVICE DISCARDED, SINGLE USE DEVICE.

    Description of Event or Problem · 0

    THE CUSTOMER REPORTED 4 FALSE POSITIVE RESULTS WITH THE IDNOW COVID-19 ASSAY PERFORMED ON A NASOPHARYNGEAL SWAB SAMPLE COLLECTED ON AN UNKNOWN DATE IN (B)(6) 2022. THIS MFR. REPORT ADDRESSES TEST THREE (3) OF FOUR (4) AND LOT NUMBER M213667 (QUANTITY 2). CONFIRMATION TESTING WAS PERFORMED USING PCR TEST (PLATFORM: UNKNOWN) ON A NASOPHARYNGEAL SAMPLE COLLECTED ON AN UNKNOWN DATE IN (B)(6) 2022, GENERATED A NEGATIVE RESULT. THE PATIENT WAS ASYMPTOMATIC. PER THE CUSTOMER, NO ADDITIONAL INFORMATION WILL BE PROVIDED.

    Description of Event or Problem · 0

    THE CUSTOMER REPORTED 4 FALSE POSITIVE RESULTS WITH THE IDNOW COVID-19 ASSAY PERFORMED ON A NASOPHARYNGEAL SWAB SAMPLE COLLECTED ON AN UNKNOWN DATE IN DECEMBER 2022. THIS MFR. REPORT ADDRESSES TEST THREE (3) OF FOUR (4) AND LOT NUMBER M213667 (QUANTITY 2). CONFIRMATION TESTING WAS PERFORMED USING PCR TEST (PLATFORM: UNKNOWN) ON A NASOPHARYNGEAL SAMPLE COLLECTED ON AN UNKNOWN DATE IN DECEMBER 2022, GENERATED A NEGATIVE RESULT. THE PATIENT WAS ASYMPTOMATIC. PER THE CUSTOMER, NO ADDITIONAL INFORMATION WILL BE PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2152272 ID NOW COVID-19 TEST KIT 24T JP REAGENTS, 2019-NOVEL CORONAVIRUS NUCLEIC ACID QJR ABBOTT DIAGNOSTICS SCARBOROUGH, INC. M213667

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown