ID NOW INFLUENZA A/B 2.0 (24T)

Additional Manufacturer Narrative

D2A - COMMON DEVICE NAME: INFLUENZA A AND INFLUENZA B MULTIPLEX NUCLEIC ACID ASSAY; REAL TIME NUCLEIC ACID AMPLIFICATION SYSTEM; RESPIRATORY VIRUS PANEL NUCLEIC ACID ASSAY SYSTEM. AN EVALUATION IS IN PROCESS. A FOLLOW-UP REPORT WILL BE SUBMITTED WHEN THE EVALUATION IS COMPLETE.

Description of Event or Problem

THE CUSTOMER REPORTED A FALSE NEGATIVE RESULT WITH THE ID NOW INFLUENZA A/B 2.0 ASSAY PERFORMED ON (B)(6) 2025 ON A NASAL SAMPLE. THE CUSTOMER REPORTED THAT THE PATIENT WAS PREGNANT AND SHOWING FLU-LIKE SYMPTOMS [FEVER, COUGH, SORE THROAT, CHILLS FOR THREE (3) DAYS, LUNG PAIN, AND PAIN WHEN BREATHING]. DUE TO THE PATIENT¿S FEVER, AND TO RULE OUT PNEUMONIA OR HEART CARDIOPULMONARY, AN X-RAY WAS PERFORMED WHICH SHOWED NO INDICATION OF PNEUMONIA OR HEART CARDIOPULMONARY. THE FOLLOWING DAY, (B)(6) 2025, THE PATIENT WAS REPORTED TO HAVE HAD WORSENING SYMPTOMS AND WENT TO AN ER. CONFIRMATION PCR (PLATFORM UNKNOWN) TESTING WAS PERFORMED USING A NASOPHARYNGEAL SWAB SAMPLE ELUTED IN VTM WHICH RESULTED IN A POSITIVE RESULT. ALTHOUGH REQUESTED, NO ADDITIONAL INFORMATION, INCLUDING PATIENT OUTCOME, WAS PROVIDED.

Additional Manufacturer Narrative

D2A - COMMON DEVICE NAME: INFLUENZA A AND INFLUENZA B MULTIPLEX NUCLEIC ACID ASSAY; REAL TIME NUCLEIC ACID AMPLIFICATION SYSTEM; RESPIRATORY VIRUS PANEL NUCLEIC ACID ASSAY SYSTEM ADDITIONAL INFORMATION: D4, LOT #, EXPIRATION DATE, PRIMARY UDI NUMBER H4, MFG DATE. INVESTIGATION SUMMARY: TESTING WAS PERFORMED AT ABBOTT DIAGNOSTICS SCARBOROUGH, INC. ON RETAINED KIT LOT 000M934181 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 427-000 LOT 000M934181 AND TEST BASE PART NUMBER 427-430/ LOT 000M934181. THE LOT MET THE REQUIRED RELEASE SPECIFICATIONS. A REVIEW OF THE COMPLAINTS REPORTED AS FALSE NEGATIVE PATIENT RESULTS (CONFIRMED AND UNCONFIRMED, CONFLICTING RESULTS) RELATED TO KIT LOT 891569 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, A POSSIBLE ASSIGNABLE ROOT CAUSE CAN BE SAMPLE INTERFERENCE.

Description of Event or Problem

THE CUSTOMER REPORTED A FALSE NEGATIVE RESULT WITH THE ID NOW INFLUENZA A/B 2.0 ASSAY PERFORMED ON (B)(6) 2025 ON A NASAL SAMPLE. THE CUSTOMER REPORTED THAT THE PATIENT WAS PREGNANT AND SHOWING FLU-LIKE SYMPTOMS [FEVER, COUGH, SORE THROAT, CHILLS FOR THREE (3) DAYS, LUNG PAIN, AND PAIN WHEN BREATHING]. DUE TO THE PATIENT¿S FEVER, AND TO RULE OUT PNEUMONIA OR HEART CARDIOPULMONARY, AN X-RAY WAS PERFORMED WHICH SHOWED NO INDICATION OF PNEUMONIA OR HEART CARDIOPULMONARY. THE FOLLOWING DAY, (B)(6) 2025, THE PATIENT WAS REPORTED TO HAVE HAD WORSENING SYMPTOMS AND WENT TO AN ER. CONFIRMATION PCR (PLATFORM UNKNOWN) TESTING WAS PERFORMED USING A NASOPHARYNGEAL SWAB SAMPLE ELUTED IN VTM WHICH RESULTED IN A POSITIVE RESULT. ALTHOUGH REQUESTED, NO ADDITIONAL INFORMATION, INCLUDING PATIENT OUTCOME, WAS PROVIDED.

Additional Manufacturer Narrative

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. ABBOTT DIAGNOSTICS SCARBOROUGH WAS UNABLE TO DETERMINE THE EXACT ROOT CAUSE OF THE REPORTED ISSUES AS NO INFORMATION WAS PROVIDED FOR INVESTIGATION.

Description of Event or Problem

THE CUSTOMER REPORTED A FALSE NEGATIVE RESULT WITH THE ID NOW INFLUENZA A/B 2.0 ASSAY PERFORMED ON (B)(6) 2025 ON A NASAL SAMPLE. THE CUSTOMER REPORTED THAT THE PATIENT WAS PREGNANT AND SHOWING FLU-LIKE SYMPTOMS [FEVER, COUGH, SORE THROAT, CHILLS FOR THREE (3) DAYS, LUNG PAIN, AND PAIN WHEN BREATHING]. DUE TO THE PATIENT¿S FEVER, AND TO RULE OUT PNEUMONIA OR HEART CARDIOPULMONARY, AN X-RAY WAS PERFORMED WHICH SHOWED NO INDICATION OF PNEUMONIA OR HEART CARDIOPULMONARY. THE FOLLOWING DAY, (B)(6) 2025, THE PATIENT WAS REPORTED TO HAVE HAD WORSENING SYMPTOMS AND WENT TO AN ER. CONFIRMATION PCR (PLATFORM UNKNOWN) TESTING WAS PERFORMED USING A NASOPHARYNGEAL SWAB SAMPLE ELUTED IN VTM WHICH RESULTED IN A POSITIVE RESULT. ALTHOUGH REQUESTED, NO ADDITIONAL INFORMATION, INCLUDING PATIENT OUTCOME, WAS PROVIDED.