FLOWFLEX PLUS RSV + FLU A/B + COVID HOME TEST

Description of Event or Problem

FALSE NEGATIVE RESULT(S). FALSE NEGATIVE RESULT FOR FLU A. THE END USER REPORTED THAT THEIR DAUGHTER (16 YEARS OLD) BEGAN EXPERIENCING SYMPTOMS OF A RESPIRATORY ILLNESS ON (B)(6) 2026. THE END USER PURCHASED THE TEST AT CVS AND ADMINISTERED THE TEST TO THEIR DAUGHTER ON (B)(6) 2026 AT ROUGHLY 5PM AND THE RESULT WAS NEGATIVE. THAT SAME EVENING THE END USER OBSERVED THEIR DAUGHTER'S SYMPTOMS WORSENING SO THEY TOOK THEIR DAUGHTER TO URGENT CARE. THEIR DAUGHTER RECEIVED A PCR TEST AT THE FACILITY AT APPROXIMATELY 7PM ON (B)(6) 2026 AND THE RESULT WAS POSITIVE FOR FLU A.

Additional Manufacturer Narrative

CASE OUTCOME: BATCH RECORDS FOR FINAL PRODUCT MANUFACTURE AND QC RECORD FOR RFC5118001 WERE REVIEWED AND NO ISSUES HAVE BEEN DETECTED IN THE MANUFACTURING PROCESS AND QUALITY CONTROL INSPECTION, AND THE MANUFACTURING PROCESS COMPLIES WITH THE SOP. RETENTION SAMPLES FROM LOT RFC5118001 WERE TESTED AND MET THE QC CRITERIA. THIRTEEN RETENTION SAMPLES WERE TESTED WITH POSITIVE CONTROL BY FOLLOWING THE FINISHED PRODUCT RELEASE PROCEDURE AND THE SAMPLING PLAN. ALL SAMPLES MEET QC SPECIFICATIONS, AND NO DEFECTS WERE OBSERVED. FIVE RETENTION SAMPLES WERE TESTED WITH HEALTH DONOR SWABS. ALL SAMPLES SHOWED CORRECT RESULTS. BASED ON THE RETENTION SAMPLE TEST RESULTS, THE CUSTOMER'S COMPLAINT CAN'T BE CONFIRMED. THE FOLLOWING FIELDS ARE UPDATED: B4, "DATE OF THIS REPORT" - DATE OF THIS FOLLOW-UP REPORT. G6, "TYPE OF REPORT" - FOLLOW-UP #1. H2, "IF FOLLOW-UP, WHAT TYPE?" - ADDED "DEVICE EVALUATION" AND "ADDITIONAL INFORMATION" H3: RETENTION LOT WAS EVALUATED. H6 "ADVERSE EVENT PROBLEM" - EVENT PROBLEM AND EVALUATION CODES ARE UPDATED. H11 "ADDITIONAL NARRATIVE/DATA" - UPDATED MANUFACTURER'S NARRATIVE.

Additional Manufacturer Narrative

THE CURRENT COMPLAINT IS PENDING INVESTIGATION FROM ACON'S CONTRACT MANUFACTURER. ACON WILL SUBMIT A FOLLOW-UP MDR UPON INVESTIGATION COMPLETION. ANY ADDITIONAL INFORMATION RECEIVED BY ACON MAY BE INCLUDED WITH A FOLLOW-UP MDR.

Description of Event or Problem

FALSE NEGATIVE RESULT(S). FALSE NEGATIVE RESULT FOR FLU A. THE END USER REPORTED THAT THEIR DAUGHTER (16 YEARS OLD) BEGAN EXPERIENCING SYMPTOMS OF A RESPIRATORY ILLNESS ON (B)(6) 2026. THE END USER PURCHASED THE TEST AT CVS AND ADMINISTERED THE TEST TO THEIR DAUGHTER ON (B)(6) 2026 AT ROUGHLY 5PM AND THE RESULT WAS NEGATIVE. THAT SAME EVENING THE END USER OBSERVED THEIR DAUGHTER'S SYMPTOMS WORSENING SO THEY TOOK THEIR DAUGHTER TO URGENT CARE. THEIR DAUGHTER RECEIVED A PCR TEST AT THE FACILITY AT APPROXIMATELY 7PM ON (B)(6) 2026 AND THE RESULT WAS POSITIVE FOR FLU A.