ARIES HSV 1&2 ASSAY

Description of Event or Problem

ON SEPTEMBER 27, 2021 FIELD QUALITY ASSURANCE NOTIFIED REGULATORY AFFAIRS OF THE CUSTOMER (B)(6) OBSERVING LEAKS WHILE USING ARIES HSV 1&2 ASSAY - IVD (PART NUMBER 50-10017, LOTS AB3600A AND AB3560A) FOLLOWING SAMPLE RUNS. THE CUSTOMER REPORTED RESIDUE BUILDUP ON THE ACTUATION BLOCK AND VALVE KEYS OF THEIR ARIES SYSTEMS. ARIES ASSAY CASSETTES ARE DESIGNED TO BE A SEALED AND CONTAINED PRODUCT. WITHIN THE CASSETTE, SAMPLE PREPARATION AND WASHING UTILIZES A SERIES OF REAGENTS TO LYSE AND PURIFY HUMAN DNA FOR PCR ANALYSIS. CASSETTES THAT LEAK WHILE BEING UTILIZED HAVE THE POTENTIAL TO LEAK THE INTERNAL REAGENTS AND PATIENT SAMPLE INTO THE ARIES SYSTEM AND THE ARIES MAGAZINE THAT LOADS INTO THE INSTRUMENT.

Additional Manufacturer Narrative

IN REVIEW OF ALL ASSOCIATED CUSTOMER-PROVIDED DOCUMENTATION AND INTERNALLY GENERATED INVESTIGATION NOTES AGAINST THE CRITERIA SET FORTH IN DOCUMENT (B)(4) (MEDICAL DEVICE REPORTING STANDARD OPERATING PROCEDURE), THIS COMPLAINT DOES MEET THE REQUIREMENTS FOR AN MDR IN THE COUNTRIES WHERE ARIES HSV 1&2 ASSAYS ARE SOLD OR DISTRIBUTED. BASED ON THE 12/2/21 EMAIL FROM (B)(4), THIS FOLLOW-UP 001 REPORT IS BEING SUBMITTED TO CHANGE IT FROM A 5 DAY REPORT TO A 30 DAY REPORT.

Additional Manufacturer Narrative

IN REVIEW OF ALL ASSOCIATED CUSTOMER-PROVIDED DOCUMENTATION AND INTERNALLY GENERATED INVESTIGATION NOTES AGAINST THE CRITERIA SET FORTH IN DOCUMENT (B)(4) (MEDICAL DEVICE REPORTING STANDARD OPERATING PROCEDURE), THIS COMPLAINT DOES MEET THE REQUIREMENTS FOR AN MDR IN THE COUNTRIES WHERE ARIES HSV 1&2 ASSAYS ARE SOLD OR DISTRIBUTED. IMPLEMENTING GUIDANCE RECEIVED FROM A RECENT FDA INSPECTION, THE ASSOCIATED RECALL INVESTIGATION WAS REASSESSED ON (B)(6) 2021 AND THE EVENT FOUND TO BE POTENTIALLY REPORTABLE AS A 5 DAY MDR. THIS MDR REPORT IS SUBMITTED WITHIN 5 DAYS OF 11/4/2021.

Description of Event or Problem

ON (B)(6) 2021 FIELD QUALITY ASSURANCE NOTIFIED REGULATORY AFFAIRS OF THE CUSTOMER MAYO FOUNDATION OBSERVING LEAKS WHILE USING ARIES HSV 1&2 ASSAY - IVD (PART NUMBER 50-10017, LOTS AB3600A AND AB3560A) FOLLOWING SAMPLE RUNS. THE CUSTOMER REPORTED RESIDUE BUILDUP ON THE ACTUATION BLOCK AND VALVE KEYS OF THEIR ARIES SYSTEMS. ARIES ASSAY CASSETTES ARE DESIGNED TO BE A SEALED AND CONTAINED PRODUCT. WITHIN THE CASSETTE, SAMPLE PREPARATION AND WASHING UTILIZES A SERIES OF REAGENTS TO LYSE AND PURIFY HUMAN DNA FOR PCR ANALYSIS. CASSETTES THAT LEAK WHILE BEING UTILIZED HAVE THE POTENTIAL TO LEAK THE INTERNAL REAGENTS AND PATIENT SAMPLE INTO THE ARIES SYSTEM AND THE ARIES MAGAZINE THAT LOADS INTO THE INSTRUMENT.