BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ID NOW COVID-19 2.0 TEST KIT 24T OUS

    MDR report key: 16273375 · Received January 31, 2023

    Report

    Report Number
    1221359-2023-00058
    Event Type
    Malfunction
    Date Received
    January 31, 2023
    Date of Event
    January 6, 2023
    Report Date
    May 26, 2023
    Manufacturer
    ABBOTT DIAGNOSTICS SCARBOROUGH, INC.
    Product Code
    QJR
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    DE
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    ADDITIONAL INFORMATION: D4 (EXPIRATION DATE), H4,E1 (COUNTRY). THIS REPORT IS BEING FILED ON AN INTERNATIONAL PRODUCT, LIST NUMBER 193-000 THAT HAS A SIMILAR PRODUCT DISTRIBUTED IN THE US, LIST NUMBER 192-000. CUSTOMER MENTIONED THROAT SAMPLE WERE USED FOR TESTING, THROAT SAMPLES WITH ID NOW COVID-19 2.0 IS CONSIDERED OFF-LABEL AND IS NOT SUPPORTED FOR USE BY ABBOTT DIAGNOSTICS SCARBOROUGH. TESTING WAS PERFORMED AT ABBOTT DIAGNOSTICS SCARBOROUGH, INC. ON RETAINED KIT LOT M219087 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 193-000 / LOT M219087, TEST BASE PART NUMBER 193-430 / LOT M219087. 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 M219087 SHOWED THAT THE COMPLAINT RATE IS (B)(4). IN CONCLUSION, ABBOTT DIAGNOSTICS SCARBOROUGH WAS UNABLE TO DETERMINE THE EXACT ROOT CAUSE OF THE REPORTED ISSUE. HOWEVER, A POSSIBLE ASSIGNABLE ROOT CAUSE IS PATIENT SAMPLE INTERFERENCE.B5, D4 (LOT #), D4(EXPIRATION DATE NULL), H3, H10(US LIST NUMBER) H3 OTHER TEXT : SINGLE-USE, DEVICE DISCARDED.

    Additional Manufacturer Narrative · 0

    ADDITIONAL INFORMATION: B5, H10 THIS REPORT IS BEING FILED ON AN INTERNATIONAL PRODUCT, LIST NUMBER 193-000 THAT HAS A SIMILAR PRODUCT DISTRIBUTED IN THE US, LIST NUMBER (B)(4). THE CUSTOMER IS UNSURE ABOUT THE SAMPLE TYPE THAT WAS USED (NASAL OR THROAT SAMPLE TYPE), THROAT SAMPLES WITH ID NOW COVID-19 2.0 IS CONSIDERED OFF-LABEL AND IS NOT SUPPORTED FOR USE BY ABBOTT DIAGNOSTICS SCARBOROUGH.. TESTING WAS PERFORMED AT ABBOTT DIAGNOSTICS SCARBOROUGH, INC. ON RETAINED KIT LOT M219087 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 193-000 / LOT M219087, TEST BASE PART NUMBER 193-430 / LOT M219087. 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 M219087 SHOWED THAT THE COMPLAINT RATE IS 0.0273%. IN CONCLUSION, ABBOTT DIAGNOSTICS SCARBOROUGH WAS UNABLE TO DETERMINE THE EXACT ROOT CAUSE OF THE REPORTED ISSUE. HOWEVER, A POSSIBLE ASSIGNABLE ROOT CAUSE IS PATIENT SAMPLE INTERFERENCE. H3 OTHER TEXT : SINGLE-USE, DEVICE DISCARDED.

    Additional Manufacturer Narrative · 0

    THIS REPORT IS BEING FILED ON AN INTERNATIONAL PRODUCT, LIST NUMBER 193-000 THAT HAS A SIMILAR PRODUCT DISTRIBUTED IN THE US, LIST NUMBER 190-000. THE REMAINDER OF THE INVESTIGATION REMAINS IN PROGRESS. A SUPPLEMENTAL REPORT WILL BE PROVIDED AFTER COMPLETION. DEVICE NOT RETURNED; SINGLE USE.

    Description of Event or Problem · 0

    THE CUSTOMER REPORTED TWELVE (12) FALSE POSITIVE RESULTS USING THE ID NOW COVID-19 ASSAY ON DIFFERENT DAYS. THIS REPORT IS FOR TEST THREE (3) OF TWELVE (12) USING LOT M219087. THE CUSTOMER REPORTED A FALSE POSITIVE RESULT ON (B)(6) 2023 DIRECTLY TESTED ON KITTED SWAB USING THROAT SAMPLE. RAPID ANTIGEN TESTING WAS PERFORMED AND GENERATED NEGATIVE RESULTS. ALTHOUGH REQUESTED, NO ADDITIONAL INFORMATION, REGARDING PATIENT OUTCOME OR TREATMENT, WAS PROVIDED.

    Description of Event or Problem · 0

    THE CUSTOMER REPORTED TWELVE (12) FALSE POSITIVE RESULTS USING THE ID NOW COVID-19 ASSAY ON DIFFERENT DAYS. THIS REPORT IS FOR TEST THREE (3) OF TWELVE (12) USING LOT M219087. THE CUSTOMER REPORTED A FALSE POSITIVE RESULT ON (B)(6) 2023 DIRECTLY TESTED ON KITTED SWAB USING UNKNOWN SAMPLE TYPE. THE CUSTOMER IS UNSURE ABOUT THE SAMPLE TYPE (NASAL OR THROAT SAMPLE TYPE). RAPID ANTIGEN TESTING WAS PERFORMED AND GENERATED NEGATIVE RESULTS. ALTHOUGH REQUESTED, NO ADDITIONAL INFORMATION, REGARDING PATIENT OUTCOME OR TREATMENT, WAS PROVIDED.

    Description of Event or Problem · 0

    THE CUSTOMER REPORTED ELEVEN (11) FALSE POSITIVE RESULTS USING THE ID NOW COVID-19 ASSAY ON DIFFERENT DAYS. THIS REPORT IS FOR TEST THREE (3) OF ELEVEN (11) USING LOT 219384. THE CUSTOMER REPORTED A FALSE POSITIVE RESULT ON (B)(6) 2023 USING A KITTED SWAB. NO REPEAT TESTING WAS PERFORMED AS PER CUSTOMER. ALTHOUGH REQUESTED, NO ADDITIONAL INFORMATION, REGARDING PATIENT OUTCOME OR TREATMENT, WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2105748 ID NOW COVID-19 2.0 TEST KIT 24T OUS REAGENTS, 2019-NOVEL CORONAVIRUS NUCLEIC ACID QJR ABBOTT DIAGNOSTICS SCARBOROUGH, INC. M219087

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown