Description of Event or Problem · 1
ON (B)(6) 2020 THREE DEVICES WERE PLACED IN PAT WHERE A NURSING TEAM MEMBER WOULD PERFORM RAPID PCR VALIDATION TEST IN TANDEM WITH THE APPROVED LABORATORY-BASED PCR METHOD. AS OF (B)(6) 2020, 69 VALIDATION SAMPLES (PREVIOUSLY RUN PATIENT SPECIMENS) WERE TESTED WITH THE FOLLOWING OUTCOMES: 21 OF 69 WERE INVALID UPON INITIAL TESTING (30.4%); 8 OF 21 PRODUCED INVALID TEST UPON REPEAT (38.1%); 48 OF 69 PRODUCED VALID INITIAL NEGATIVE RESULT (69.6%); 13 OF 21 PRODUCED VALID NEGATIVE AFTER REPEAT TESTING (61.9%). THE VENDOR WAS CONTACTED ON OCT 27, 2020 TO REPORT HIGH INVALID RATE. VENDOR INDICATED THEY HAD RECEIVED PRIOR REPORTS OF INVALID TESTS. BASED ON THE FOLLOWING, UNDER CAP STANDARD GEN.20351 AND (B)(6) DOCUMENT 635.079, "MEDICAL EQUIPMENT SEQUESTRATION FDA REPORTING", THE LAB REPORTED QUALITY CONCERNS TO THE FDA. VERY HIGH INVALID RATE (30.4%) ON INITIAL TESTING. VERY HIGH INVALID RATE (38.1%) UPON REPEAT TESTING. RISK MANAGEMENT WAS NOT CONTACTED SINCE NO DIRECT PATIENT TESTING PERFORMED, THIS WAS ONLY VALIDATION STUDY. OTHER USERS CONNECTED WITH (B)(6) HAVE REPORTED SIMILAR QUALITY PERFORMANCE CONCERNS AND HAVE CHOSEN TO NOT PROCEED WITH TESTING ON THIS DEVICE. ALTHOUGH PANDEMIC MANAGEMENT REQUIRES OUR LABORATORY SERVICES TO MEET UNPRECEDENTED DEMANDS, BASIC QUALITY MANAGEMENT STANDARDS STILL APPLY. BASED ON STUDY RESULTS, THIS DEVICE DOES NOT MEET BASIC QUALITY STANDARDS. FDA SAFETY REPORT ID# (B)(4).