ID NOW INFLUENZA A/B 2.0 (24T)

Additional Manufacturer Narrative

A2 - AGE AT TIME OF EVENT: 9 YEARS AND 4 MONTHS OLD 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 PATIENT WAS SENT HOME WITHOUT TREATMENT. THE PATIENT WAS REPORTED TO HAVE STARTED EXPERIENCING SYMPTOMS THAT DAY, AND THEY WORSENED FOLLOWING THE OFFICE VISIT. FOUR HOURS LATER, THE PATIENT WENT TO THE EMERGENCY ROOM, WHERE CONFIRMATION PCR (UNKNOWN PLATFORM) TESTING WAS PERFORMED GENERATING A POSITIVE RESULT. THE PATIENT WAS REPORTED TO BE EXPERIENCING THE FOLLOWING SYMPTOMS AT HOME, PRIOR TO THE EMERGENCY ROOM VISIT: HYPOXIA, RESPIRATORY DISTRESS, DIFFICULTY BREATHING, AND SHORTNESS OF BREATH. THE PATIENT WAS HOSPITALIZED AND RECEIVED TREATMENT (UNKNOWN TYPE). ALTHOUGH REQUESTED, NO ADDITIONAL INFORMATION INCLUDING PATIENT OUTCOME WAS PROVIDED.

Additional Manufacturer Narrative

A2 - AGE AT TIME OF EVENT: 9 YEARS AND 4 MONTHS OLD. 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 TESTING WAS PERFORMED AT ABBOTT DIAGNOSTICS SCARBOROUGH, INC. ON RETAINED KIT LOT 000M919576 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 000M919576, TEST BASE PART NUMBER 427-430/ LOT 000M919576. 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 000M919576 SHOWED THAT THE COMPLAINT RATE IS (B)(4)%. ABBOTT DIAGNOSTICS SCARBOROUGH, INC. WAS UNABLE TO DETERMINE THE EXACT ROOT CAUSE OF THE REPORTED ISSUE.

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 PATIENT WAS SENT HOME WITHOUT TREATMENT. THE PATIENT WAS REPORTED TO HAVE STARTED EXPERIENCING SYMPTOMS THAT DAY, AND THEY WORSENED FOLLOWING THE OFFICE VISIT. FOUR HOURS LATER, THE PATIENT WENT TO THE EMERGENCY ROOM, WHERE CONFIRMATION PCR (UNKNOWN PLATFORM) TESTING WAS PERFORMED GENERATING A POSITIVE RESULT. THE PATIENT WAS REPORTED TO BE EXPERIENCING THE FOLLOWING SYMPTOMS AT HOME, PRIOR TO THE EMERGENCY ROOM VISIT: HYPOXIA, RESPIRATORY DISTRESS, DIFFICULTY BREATHING, AND SHORTNESS OF BREATH. THE PATIENT WAS HOSPITALIZED AND RECEIVED TREATMENT (UNKNOWN TYPE). ALTHOUGH REQUESTED, NO ADDITIONAL INFORMATION INCLUDING PATIENT OUTCOME WAS PROVIDED.