ROCHE 6800
Received Sep 9, 2022 · Event occurred Sep 3, 2022
Report MW5111963 · MDR key 15401727
Device
Product problems
- Product Quality Problem
- Incorrect, Inadequate or Imprecise Result or Readings
Patient
40 YR · Female
- No Clinical Signs, Symptoms or Conditions
- No Clinical Signs, Symptoms or Conditions
Narrative
Description of Event or Problem
ROCHE CT/NG ON THE 6800 CONSISTENTLY PROVIDES INVALID RESULTS. PATIENT HAD INVALID GONORRHEA AND WHEN REPEATED WAS DETECTED, THEN REPEATED AS INVALID. WE HAVE ASKED ROCHE TO SOLVE THIS PROBLEM AND THEY KEEP SAYING IT IS CARBOMER BUT THE CLINICIAN AND PATIENT SAID THEY WERE NOT USING ANY PRODUCTS THAT CONTAIN CARBOMER. THE PATIENT SAID SHE WOULD LEAVE HER SPOUSE OVER THIS. WE HAVE AN INVALID RATE OF 14% WHICH IS UNACCEPTABLE FOR MOLECULAR METHODS FOR STI TESTING. WE HAVE BEEN ASKING ROCHE TO FIX THIS PROBLEM AND THEY TOLD US TO USE URINE INSTEAD OF SWABS BECAUSE IT DOES NOT HAVE THE SAME PROBLEMS. THIS IS NOT FIXING THE PROBLEM, RATHER AVOIDING IT. FDA SAFETY REPORT ID # (B)(4).