COBAS AMPLICOR CT/NG TEST
Received Mar 22, 2011 · Event occurred Feb 21, 2011
Report 2243471-2011-00044 · MDR key 2026657
Device
Product problems
- Off-Label Use
- Incorrect Or Inadequate Test Results
Patient
Not reported
- No Information
Narrative
Additional Manufacturer Narrative
A DEFINITIVE CONCLUSION CANNOT BE DRAWN AT THIS TIME, AS THE INVESTIGATION INTO THIS ISSUE IS ONGOING. THE OUTCOME OF THIS INVESTIGATION WILL BE COMMUNICATED THROUGH A FOLLOW-UP REPORT. (B)(4).
Additional Manufacturer Narrative
DEVICE EVALUATED BY MANUFACTURER - YES. RESULT: FAILURE TO SERVICE/MAINTAIN ACCORDING TO MANUFACTURER'S SPECIFICATION. DEVICE FAILURE RELATED TO MAINTENANCE. OFF-LABEL, UNAPPROVED OR CONTRAINDICATED USE. DURING THE INVESTIGATION, IT WAS LEARNED THAT THE SITE WAS RINSING THE WASH CONTAINER RESERVOIR WITH TAP WATER AND NOT ALLOWING IT TO DRY PRIOR TO PREPARING THE WASH BUFFER. THE COBAS AMPLICOR ANALYZER OPERATOR'S MANUAL WEEKLY MAINTENANCE PROCEDURES SPECIFY RINSING THE WASH RESERVOIR WITH DISTILLED OR DE-IONIZED WATER ONLY. IT IS SUSPECTED THAT INSTRUMENT CONTAMINATION WAS INTRODUCED WITH THE TAP WATER RINSING OF THE RESERVOIR, WHICH LED TO AN INCREASE IN GREY ZONE AND DISCREPANT RESULTS. THE INCREASED GREY ZONE RESULTS RESOLVED AFTER THE CUSTOMER INSTITUTED THE CHANGE TO DISTILLED WATER RINSING. A SUBSEQUENT FOLLOW UP WITH THE AFFILIATE CONFIRMED THAT THE CUSTOMER HAS NOT HAD ANY FURTHER ISSUES WITH DISCREPANT OR INCREASED GREY ZONE RESULTS SINCE THE CORRECT MAINTENANCE PROCEDURE AT THE SITE WAS INSTITUTED. FOR THE DISCREPANT RESULTS THAT WERE PRODUCED, IT IS UNKNOWN WHICH RESULTS WERE CORRECT SINCE THE CUSTOMER PERFORMED INITIAL AND REPEAT TESTING ON A POTENTIALLY CONTAMINATED ANALYZER. PATIENT INFORMATION WAS NOT PROVIDED AND IS NOT AVAILABLE NO PRODUCT NON-CONFORMANCE WAS IDENTIFIED, AS THE ISSUE IS ATTRIBUTED TO AN ISOLATED, SITE SPECIFIC ISSUE CAUSED BY IMPROPER HANDLING OF THE COBAS AMPLICOR ANALYZER WASH RESERVOIR. (B)(4).
Description of Event or Problem
A CUSTOMER SITE IN UNITED STATES REPORTED THAT THEY RECEIVED DISCREPANT NEISSERIA GONORRHOEAE (NG) RESULTS WHEN USING THE COBAS AMPLICOR CT/NG TEST. THE CUSTOMER SITE PROTOCOL IS TO REPEAT TEST ALL (B)(6) RESULTS , WHICH IS AN OFF-LABEL PRACTICE. THE CUSTOMER ALSO INDICATED THAT THEY RECEIVED DISCREPANT CHLAMYDIA TRACHOMATIS (CT) RESULTS. THE CT DISCREPANT RESULTS ARE BEING ADDRESSED IN MDR 2243471-2011-00038. ON (B)(6) 2011, THEY OBTAINED THE FOLLOWING RESULTS FOR SAMPLE (B)(6). WHEN REPEATED ON (B)(6) 2011, THE RESULTS WERE (B)(6). THE (B)(6) RESULT WAS REPORTED TO THE PHYSICIAN. IT IS UNKNOWN IF ANY PATIENT TREATMENT WAS AFFECTED.