BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ID NOW COVID-19 2.0 TEST KIT 24T OUS

    MDR report key: 19604532 · Received June 25, 2024

    Report

    Report Number
    1221359-2024-00427
    Event Type
    Malfunction
    Date Received
    June 25, 2024
    Date of Event
    May 30, 2024
    Report Date
    August 1, 2024
    Manufacturer
    ABBOTT DIAGNOSTICS SCARBOROUGH, INC.
    Product Code
    QWR
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GB
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    B3 & B5: ADDITIONAL INFORMATION PROVIDED INCLUDING ADDITIONAL TESTS PERFORMED AND DATE OF EVENT D4 & H4: ADDITIONAL INFORMATION PROVIDED INCLUDING LOT NUMBER, EXP DATE, MFG DATE DETAILS H6 (HEALTH EFFECT IMPACT CODE CHANGED TO F26): ADDITIONAL INFORMATION PROVIDED INDICATING NO PATIENT WAS IMPACTED D2A: SIMPLE POINT-OF-CARE DEVICE TO DETECT SAR-COV-2 NUCLEIC ACID TARGETS FROM CLINICAL SPECIMENS IN NEAR-PATIENT SETTINGS 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. THE REMAINDER OF THE INVESTIGATION REMAINS IN PROGRESS. A SUPPLEMENTAL REPORT WILL BE PROVIDED AFTER COMPLETION.

    Additional Manufacturer Narrative · 0

    D2A: SIMPLE POINT-OF-CARE DEVICE TO DETECT SAR-COV-2 NUCLEIC ACID TARGETS FROM CLINICAL SPECIMENS IN NEAR-PATIENT SETTINGS. 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. TESTING WAS PERFORMED AT ABBOTT DIAGNOSTICS SCARBOROUGH, INC. ON RETAINED KIT LOT M807001 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: M807001, TEST BASE PART NUMBER 192-430/ LOT: M807001. 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 M807001 SHOWED THAT THE COMPLAINT RATE IS (B)(4). ABBOTT DIAGNOSTICS SCARBOROUGH, INC. WAS UNABLE TO DETERMINE THE EXACT ROOT CAUSE OF THE REPORTED ISSUE; HOWEVER, IT COULD HAVE POSSIBLY BEEN RELATED TO SAMPLE INTERFERENCE OR CROSS CONTAMINATION.

    Additional Manufacturer Narrative · 0

    B3: THE DATE PROVIDED IS AN APPROXIMATION AS THE EXACT EVENT DATE WAS NOT PROVIDED. D2A: SIMPLE POINT-OF-CARE DEVICE TO DETECT SAR-COV-2 NUCLEIC ACID TARGETS FROM CLINICAL SPECIMENS IN NEAR-PATIENT SETTINGS 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. THE REMAINDER OF THE INVESTIGATION REMAINS IN PROGRESS. A SUPPLEMENTAL REPORT WILL BE PROVIDED AFTER COMPLETION.

    Description of Event or Problem · 0

    THE CUSTOMER REPORTED SEVEN (7) FALSE POSITIVE RESULTS WITH THE ID NOW COVID-19 ASSAY 2.0 PERFORMED ON TWO (2) DIFFERENT LOTS ON MULTIPLE PATIENTS ON VARIOUS DATES. THIS MFR. REPORT ADDRESSES LOT M807001 (QUANTITY: 6) AND TEST THREE (3) OF SEVEN (7). THE CUSTOMER REPORTED A FALSE POSITIVE RESULT WITH THE ID NOW COVID-19 2.0 ASSAY PERFORMED ON 30MAY2024 ON A NASAL SAMPLE. CONFIRMATION TESTING VIA PCR (PLATFORM: UNKNOWN) WAS PERFORMED ON AN UNKNOWN DATE AND GENERATED A NEGATIVE RESULT. 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'S TREATMENT.

    Description of Event or Problem · 0

    THE CUSTOMER REPORTED SEVEN (7) FALSE POSITIVE RESULTS WITH THE ID NOW COVID-19 ASSAY 2.0 PERFORMED ON TWO (2) DIFFERENT LOTS ON MULTIPLE PATIENTS ON VARIOUS DATES. THIS MFR. REPORT ADDRESSES LOT M807001 (QUANTITY: (B)(4)) AND TEST THREE (3) OF SEVEN (7). THE CUSTOMER REPORTED A FALSE POSITIVE RESULT WITH THE ID NOW COVID-19 2.0 ASSAY PERFORMED ON (B)(6) 2024 ON A NASAL SAMPLE. CONFIRMATION TESTING VIA PCR (PLATFORM: UNKNOWN) WAS PERFORMED ON AN UNKNOWN DATE AND GENERATED A NEGATIVE RESULT. 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'S TREATMENT.

    Description of Event or Problem · 0

    THE CUSTOMER REPORTED THREE (3) FALSE POSITIVE RESULTS WITH THE ID NOW COVID-19 ASSAY 2.0 PERFORMED ON MULTIPLE PATIENTS ON AN UNKNOWN DATE ON UNKNOWN SAMPLE TYPES. THIS MFR. REPORT ADDRESSES TEST THREE (3) OF THREE (3). THE CUSTOMER REPORTED A FALSE POSITIVE RESULT WITH THE ID NOW COVID-19 ASSAY 2.0 PERFORMED ON AN UNKNOWN DATE ON AN UNKNOWN SAMPLE TYPE. CONFIRMATION TESTING WAS PERFORMED VIA PCR (PLATFORM: UNKNOWN) ON AN UNKNOWN DATE WHICH GENERATED A NEGATIVE RESULT. NO ADDITIONAL PATIENT INFORMATION, INCLUDING TREATMENT AND OUTCOME, WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    208702 ID NOW COVID-19 2.0 TEST KIT 24T OUS SIMPLE POINT-OF-CARE DEVICE TO DETECT SAR-COV-2 NUCLEIC ACID TARGETS QWR ABBOTT DIAGNOSTICS SCARBOROUGH, INC. M807001

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown