BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ID NOW COVID-19 2.0 TEST KIT 24T OUS

    MDR report key: 16828615 · Received April 27, 2023

    Report

    Report Number
    1221359-2023-00923
    Event Type
    Malfunction
    Date Received
    April 27, 2023
    Date of Event
    February 19, 2023
    Report Date
    July 20, 2023
    Manufacturer
    ABBOTT DIAGNOSTICS SCARBOROUGH, INC.
    Product Code
    QJR
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GB
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    UPDATED ADDITIONAL INFORMATION: EXPIRATION DATE AND MANUFACTURE DATE. D4: THE CUSTOMER WAS NOT ABLE TO CONFIRM WHICH LOT WAS INVOLVED WITH THIS EVENT, BUT PROVIDED THE POSSIBLE LOTS BELOW: LOT: M219370; EXPIRATION DATE: 29OCT2023; MANUFACTURE DATE: 01OCT2022. LOT: 1096698; EXPIRATION DATE: 02DEC2023; MANUFACTURE DATE: 05NOV2022. G4: SIMILAR PRODUCT TO 192-000. TESTING WAS PERFORMED AT ABBOTT DIAGNOSTICS SCARBOROUGH, INC. ON RETAINED KIT LOT M219370 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 193-000 / LOT M219370 AND TEST BASE PART NUMBER 192-430 / LOT M219370. 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 M219370 SHOWED THAT THE COMPLAINT RATE IS 0.00929%. ABBOTT DIAGNOSTICS SCARBOROUGH, INC. WAS UNABLE TO DETERMINE THE EXACT ROOT CAUSE OF THE REPORTED ISSUE, AS THE LOGFILES WERE NOT PROVIDED BY THE CUSTOMER. TESTING WAS PERFORMED AT ABBOTT DIAGNOSTICS SCARBOROUGH, INC. ON RETAINED KIT LOT 1096698 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 193-000 / LOT 1096698 AND TEST BASE PART NUMBER 192-430 / LOT 1096698. 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 1096698 SHOWED THAT THE COMPLAINT RATE IS (B)(4)%. ABBOTT DIAGNOSTICS SCARBOROUGH, INC. WAS UNABLE TO DETERMINE THE EXACT ROOT CAUSE OF THE REPORTED ISSUE, AS THE LOGFILES WERE NOT PROVIDED BY THE CUSTOMER.

    Additional Manufacturer Narrative · 0

    D4: THE CUSTOMER WAS NOT ABLE TO CONFIRM WHICH LOT WAS INVOLVED WITH THIS EVENT, BUT PROVIDED THE POSSIBLE LOTS BELOW: LOT: M219370; EXPIRATION DATE: NI; MANUFACTURE DATE: NI. LOT: 1096698; EXPIRATION DATE: NI; MANUFACTURE DATE: NI. G4: SIMILAR PRODUCT TO 192-000. TESTING WAS PERFORMED AT ABBOTT DIAGNOSTICS SCARBOROUGH, INC. ON RETAINED KIT LOT M219370 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 193-000 / LOT M219370 AND TEST BASE PART NUMBER 192-430 / LOT M219370. 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 M219370 SHOWED THAT THE COMPLAINT RATE IS 0.00929%. ABBOTT DIAGNOSTICS SCARBOROUGH, INC. WAS UNABLE TO DETERMINE THE EXACT ROOT CAUSE OF THE REPORTED ISSUE, AS THE LOGFILES WERE NOT PROVIDED BY THE CUSTOMER. TESTING WAS PERFORMED AT ABBOTT DIAGNOSTICS SCARBOROUGH, INC. ON RETAINED KIT LOT 1096698 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 193-000 / LOT 1096698 AND TEST BASE PART NUMBER 192-430 / LOT 1096698. 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 1096698 SHOWED THAT THE COMPLAINT RATE IS 0.00378%. ABBOTT DIAGNOSTICS SCARBOROUGH, INC. WAS UNABLE TO DETERMINE THE EXACT ROOT CAUSE OF THE REPORTED ISSUE, AS THE LOGFILES WERE NOT PROVIDED BY THE CUSTOMER.

    Additional Manufacturer Narrative · 0

    D4: THE CUSTOMER WAS NOT ABLE TO CONFIRM WHICH LOT WAS INVOLVED WITH THIS EVENT, BUT PROVIDED THE POSSIBLE LOTS BELOW: LOT: M219370; EXPIRATION DATE: NI; MANUFACTURE DATE: NI. LOT: 1096698; EXPIRATION DATE: NI; MANUFACTURE DATE: NI. G4: SIMILAR PRODUCT TO 192-000. THE INVESTIGATION IS ONGOING. A SUPPLEMENT REPORT WILL BE SENT UPON INVESTIGATION COMPLETION OR RECEIPT OF ADDITIONAL INFORMATION. H3 OTHER TEXT : SINGLE USE DEVICE, DISCARDED.

    Description of Event or Problem · 0

    THE CUSTOMER REPORTED 231 FALSE POSITIVE RESULTS WITH THE ID NOW COVID-19 2.0 ASSAY PERFORMED BETWEEN (B)(6) 2023 USING VARIOUS LOTS ON MULTIPLE PATIENTS. THE CUSTOMER REPORTED USING THREE DIFFERENT LOTS (M219370, 1096698, AND 1096141) WITHIN THIS PERIOD, HOWEVER, FOR CERTAIN DATES, COULD NOT SPECIFY WHICH LOT NUMBER ATTRIBUTED TO THE FALSE RESULTS. THIS MFR. REPORT ADDRESSES TEST ONE HUNDRED EIGHTY-TWO (182) OF TWO HUNDRED THIRTY-ONE (231) USING EITHER LOT M219370 OR 1096698. THE CUSTOMER REPORTED A FALSE POSITIVE RESULT WITH THE ID NOW COVID-19 2.0 ASSAY PERFORMED ON A DIRECT-TESTED NASAL SWAB. CONFIRMATION TESTING VIA CEPHEID PCR WAS PERFORMED USING AN UNKNOWN SAMPLE TYPE AND GENERATED A NEGATIVE RESULT. THE CUSTOMER STATED THAT NO PATIENT INFORMATION IS AVAILABLE. ALTHOUGH REQUESTED, NO ADDITIONAL INFORMATION WAS PROVIDED.

    Description of Event or Problem · 0

    THE CUSTOMER REPORTED 231 FALSE POSITIVE RESULTS WITH THE ID NOW COVID-19 2.0 ASSAY PERFORMED BETWEEN (B)(6) 2023 USING VARIOUS LOTS ON MULTIPLE PATIENTS. THE CUSTOMER REPORTED USING THREE DIFFERENT LOTS (M219370, 1096698, AND 1096141) WITHIN THIS PERIOD, HOWEVER, FOR CERTAIN DATES, COULD NOT SPECIFY WHICH LOT NUMBER ATTRIBUTED TO THE FALSE RESULTS. THIS MFR. REPORT ADDRESSES TEST ONE HUNDRED EIGHTY-TWO (182) OF TWO HUNDRED THIRTY-ONE (231) USING EITHER LOT M219370 OR 1096698. THE CUSTOMER REPORTED A FALSE POSITIVE RESULT WITH THE ID NOW COVID-19 2.0 ASSAY PERFORMED ON A DIRECT-TESTED NASAL SWAB. CONFIRMATION TESTING VIA CEPHEID PCR WAS PERFORMED USING AN UNKNOWN SAMPLE TYPE AND GENERATED A NEGATIVE RESULT. THE CUSTOMER STATED THAT NO PATIENT INFORMATION IS AVAILABLE. ALTHOUGH REQUESTED, NO ADDITIONAL INFORMATION WAS PROVIDED.

    Description of Event or Problem · 0

    THE CUSTOMER REPORTED 231 FALSE POSITIVE RESULTS WITH THE ID NOW COVID-19 2.0 ASSAY PERFORMED BETWEEN (B)(6) 2023 USING VARIOUS LOTS ON MULTIPLE PATIENTS. THE CUSTOMER REPORTED USING THREE DIFFERENT LOTS (M219370, 1096698, AND 1096141) WITHIN THIS PERIOD, HOWEVER, FOR CERTAIN DATES, COULD NOT SPECIFY WHICH LOT NUMBER ATTRIBUTED TO THE FALSE RESULTS. THIS MFR. REPORT ADDRESSES TEST ONE HUNDRED EIGHTY-TWO (182) OF TWO HUNDRED THIRTY-ONE (231) USING EITHER LOT M219370 OR 1096698. THE CUSTOMER REPORTED A FALSE POSITIVE RESULT WITH THE ID NOW COVID-19 2.0 ASSAY PERFORMED ON A DIRECT-TESTED NASAL SWAB. CONFIRMATION TESTING VIA CEPHEID PCR WAS PERFORMED USING AN UNKNOWN SAMPLE TYPE AND GENERATED A NEGATIVE RESULT. THE CUSTOMER STATED THAT NO PATIENT INFORMATION IS AVAILABLE. ALTHOUGH REQUESTED, NO ADDITIONAL INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1235548 ID NOW COVID-19 2.0 TEST KIT 24T OUS REAGENTS, 2019-NOVEL CORONAVIRUS NUCLEIC ACID QJR ABBOTT DIAGNOSTICS SCARBOROUGH, INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown