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

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

INVALID RESULT(S): CUSTOMER PURCHASED A FLOWFLEX PLUS 4-IN-1 KIT WITH INVALID RESULTS. ONLY CONTROL LINE APPEARED ON RSV SIDE OF THE TEST CASSETTE. SHE FOLLOWED THE DIRECTIONS EXACTLY AND WAITED 15 MINUTES. THE SAMPLE WAS DISPENSED INTO THE S WELL. THE KIT WAS PURCHASED AT WALGREENS.

Additional Manufacturer Narrative

CASE OUTCOME: BATCH RECORDS FOR FINAL PRODUCT MANUFACTURE AND QC RECORD FOR RFC5118002 WERE REVIEWED AND IT WAS DETERMINED THAT THE ISSUE IS NOT PRESENT ON ANY OTHER PRODUCT AND THE PRODUCT WAS CONSIDERED ACCEPTABLE. ACCORDING TO THE RECORDS REVIEWED, THERE ARE NO NCMRS ASSOCIATED WITH THIS LOT. A DEVIATION WAS REGISTERED WITH NO. P2511005. BASED ON THE RETENTION SAMPLE TEST RESULTS, THE CUSTOMER'S COMPLAINT COULD NOT 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.

Description of Event or Problem

INVALID RESULT(S): CUSTOMER PURCHASED A FLOWFLEX PLUS 4-IN-1 KIT WITH INVALID RESULTS. ONLY CONTROL LINE APPEARED ON RSV SIDE OF THE TEST CASSETTE. SHE FOLLOWED THE DIRECTIONS EXACTLY AND WAITED 15 MINUTES. THE SAMPLE WAS DISPENSED INTO THE S WELL. THE KIT WAS PURCHASED AT WALGREENS. PICTURE PROVIDED.