ID NOW RSV TEST KIT 24T

Additional Manufacturer Narrative

D2A: RESPIRATORY VIRUS PANEL NUCLEIC ACID ASSAY SYSTEM; REAL TIME NUCLEIC ACID AMPLIFICATION SYSTEM; HUMAN METAPNEUMOVIRUS (HMPV) RNA ASSAY SYSTEM. D2B: OCC, OOI, OEM. A MEDICAL EVALUATION WAS OBTAINED REGARDING THE REPORTED FALSE NEGATIVE ID NOW RSV TEST RESULT. THE MEDICAL REVIEWER NOTED THAT AN INITIAL RSV TEST PERFORMED SHORTLY AFTER SYMPTOM ONSET WAS NEGATIVE, WHILE A REPEAT TEST CONDUCTED FOLLOWING WORSENING SYMPTOMS AND SUBSEQUENT HOSPITALIZATION WAS POSITIVE, INDICATING THE INITIAL RESULT WAS A FALSE NEGATIVE. NO DEVICE MALFUNCTION WAS ALLEGED. THE MEDICAL REVIEWER INDICATED THAT THE EVENT MEETS THE DEFINITION OF A SERIOUS INJURY DUE TO THE REPORTED HOSPITALIZATION; HOWEVER, THE SEVERE RSV ILLNESS WAS CONSIDERED CONSISTENT WITH THE NATURAL PROGRESSION OF RSV INFECTION IN A PEDIATRIC PATIENT AND, BASED ON THE AVAILABLE INFORMATION, DOES NOT DEMONSTRATE A CAUSAL RELATIONSHIP TO THE FALSE NEGATIVE TEST RESULT. THE REMAINDER OF THE INVESTIGATION REMAINS IN PROGRESS. A SUPPLEMENTAL REPORT WILL BE PROVIDED AFTER COMPLETION.

Description of Event or Problem

THE CUSTOMER REPORTED A FALSE NEGATIVE RESULT WITH THE ID NOW RSV TEST PERFORMED ON (B)(6) 2026 ON AN UNKNOWN SAMPLE TYPE. PER THE CUSTOMER, THE 4-MONTH-OLD PATIENT WAS SYMPTOMATIC AND THEIR SYMPTOMS WORSENED THE NEXT DAY. THEY WERE HOSPITALIZED ON (B)(6) 2026 WHERE ADDITIONAL RSV TESTING WAS PERFORMED VIA AN UNKNOWN METHOD WHICH GENERATED A POSITIVE RESULT. PER THE CUSTOMER, AFTER TESTING POSITIVE AND BEING HOSPITALIZED, THE 4-MONTH-OLD DEVELOPED "SEVERE DISEASE". ALTHOUGH REQUESTED, NO ADDITIONAL PATIENT INFORMATION, INCLUDING TREATMENT AND OUTCOME, WILL BE PROVIDED BY THE CUSTOMER