BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ID NOW COVID-19 2.0 TEST KIT 24T JAPAN

    MDR report key: 16989121 · Received May 23, 2023

    Report

    Report Number
    1221359-2023-01151
    Event Type
    Malfunction
    Date Received
    May 23, 2023
    Date of Event
    May 17, 2023
    Report Date
    June 27, 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

    TESTING WAS PERFORMED AT ABBOTT DIAGNOSTICS SCARBOROUGH, INC. ON RETAINED KIT LOT M228667 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 192-000J / LOT M228667 AND TEST BASE PART NUMBER 192-430 / LOT M228667. 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 M228667 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.

    Additional Manufacturer Narrative · 0

    TESTING WAS PERFORMED AT ABBOTT DIAGNOSTICS SCARBOROUGH, INC. ON RETAINED KIT LOT M228667 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 192-000J / LOT M228667 AND TEST BASE PART NUMBER 192-430 / LOT M228667. 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 M228667 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.

    Additional Manufacturer Narrative · 0

    THE REQUIRED INTAKE INFORMATION TO ENABLE FURTHER INVESTIGATION, SUCH AS THE KIT'S LOT NUMBER, WAS NOT PROVIDED AND AN INVESTIGATION WAS NOT ABLE TO BE PERFORMED. NOTWITHSTANDING, A REVIEW OF COMPLAINTS' TREND REVEALS THAT ALL LOTS WITHIN EXPIRY DATING ARE PERFORMING ACCORDING TO THE STATEMENTS MADE IN THE PACKAGE INSERT. IN CONCLUSION, ABBOTT DIAGNOSTICS SCARBOROUGH WAS UNABLE TO DETERMINE THE EXACT ROOT CAUSE OF THE REPORTED ISSUES AS NO INFORMATION WAS PROVIDED FOR INVESTIGATION. H3 OTHER TEXT : DEVICE DISCARDED, SINGLE USE.

    Additional Manufacturer Narrative · 0

    ADDITIONAL DATA: NEW INFORMATION WAS RECEIVED ON 26MAY2023 FROM THE CUSTOMER STATED THAT THERE WERE 7 FALSE POSITIVE RESULTS WITH TWO LOT NUMBERS INVOLVED (M229061, M228667). UPDATED DATA: H6, D4 (LOT NUMBER). B5: EVENT DESCRIPTION UPDATED BASED ON NEW INFORMATION PROVIDED BY CUSTOMER ON 26MAY2023. THE INVESTIGATION IS STILL IN PROGRESS. A SUPPLEMENTAL REPORT WILL BE PROVIDED AFTER COMPLETION. H3 OTHER TEXT : DEVICE DISCARDED, SINGLE USE.

    Description of Event or Problem · 0

    THE CUSTOMER REPORTED SEVEN (7) FALSE POSITIVE RESULTS WITH ID NOW COVID-19 2.0 TEST-KIT ON (B)(6) 2023. PER THE CUSTOMER, THE PATIENT RECEIVED POSITIVE RESULTS WITH ID NOW COVID-19 2.0 TEST-KIT, AND A NEGATIVE RESULT ON A PCR TEST. THIS MFR. REPORT ADDRESSES TEST ONE (1) OF SEVEN (7) TESTS, LOT NUMBER INVOLVED M228667 QUANTITY (B)(4). NO ADDITIONAL PATIENT INFORMATION, INCLUDING TREATMENT AND OUTCOME, WAS PROVIDED.

    Description of Event or Problem · 0

    THE CUSTOMER REPORTED SEVEN (7) FALSE POSITIVE RESULTS WITH ID NOW COVID-19 2.0 TEST-KIT ON 17MAY2023. PER THE CUSTOMER, THE PATIENT RECEIVED POSITIVE RESULTS WITH ID NOW COVID-19 2.0 TEST-KIT, AND A NEGATIVE RESULT ON A PCR TEST. THIS MFR. REPORT ADDRESSES TEST ONE (1) OF SEVEN (7) TESTS, LOT NUMBER INVOLVED M228667 QUANTITY (5). NO ADDITIONAL PATIENT INFORMATION, INCLUDING TREATMENT AND OUTCOME, WAS PROVIDED.

    Description of Event or Problem · 0

    THE CUSTOMER REPORTED AN UNKNOWN NUMBER OF FALSE POSITIVE RESULTS WITH ID NOW COVID-19 2.0 TEST-KIT ON (B)(6) 2023.THE CUSTOMER STATED GETTING "A FEW FALSE POSITIVE RESULTS". PER THE CUSTOMER, THE PATIENT RECEIVED POSITIVE RESULTS WITH ID NOW COVID-19 2.0 TEST-KIT, AND A NEGATIVE RESULT ON A PCR TEST. NO ADDITIONAL PATIENT INFORMATION, INCLUDING TREATMENT AND OUTCOME, WAS PROVIDED.

    Description of Event or Problem · 0

    THE CUSTOMER REPORTED SEVEN (7) FALSE POSITIVE RESULTS WITH ID NOW COVID-19 2.0 TEST-KIT ON (B)(6) 2023. PER THE CUSTOMER, THE PATIENT RECEIVED POSITIVE RESULTS WITH ID NOW COVID-19 2.0 TEST-KIT, AND A NEGATIVE RESULT ON A PCR TEST. THIS MFR. REPORT ADDRESSES TEST ONE (1) OF SEVEN (7) TESTS, LOT NUMBER INVOLVED M228667 QUANTITY (5). NO ADDITIONAL PATIENT INFORMATION, INCLUDING TREATMENT AND OUTCOME, WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1450409 ID NOW COVID-19 2.0 TEST KIT 24T JAPAN REAGENTS, 2019-NOVEL CORONAVIRUS NUCLEIC ACID QJR ABBOTT DIAGNOSTICS SCARBOROUGH, INC. M228667

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown