COBAS® INFLUENZA A/B & RSV NUCLEIC ACID TEST FOR USE ON THE COBAS® LIAT® SYSTEM
Received Oct 30, 2024 · Event occurred Oct 7, 2024
Report 2243471-2024-03134 · MDR key 20569037
Device
Generic name
Respiratory Virus Panel Nucleic Acid Assay System
Manufacturer
Roche Molecular Systems, Inc. - BranchburgCatalog number
08160104190
Lot number
ASKU
Product problems
- False Positive Result
- False Positive Result
Patient
NA · Unknown
- No Clinical Signs, Symptoms or Conditions
- No Clinical Signs, Symptoms or Conditions
Narrative
Additional Manufacturer Narrative
A REVIEW OF THE DATA SHOWED THAT THE ALLEGED SAMPLE INITIALLY GENERATED A POSITIVE RESULT FOR THE INFLUENZA A AND RSV TARGETS. THE REPEAT RUN WAS PERFORMED WITH A DIFFERENT INSTRUMENT USING THE COBAS SARS-COV-2 & INFLUENZA A/B TEST WHICH GENERATED NEGATIVE RESULTS FOR ALL 3 TARGETS. THE DATA REVIEW IDENTIFIED 2 MORE SAMPLES GENERATING THE SAME DISCREPANCY. NOTE, SAMPLE 3 WAS ALSO REPEATED ON THE COBAS® INFLUENZA A/B & RSV ASSAY WHICH GENERATED NEGATIVE RESULTS FOR ALL 3 TARGETS. THE INVESTIGATION IS COMPLETE AND REVEALED THAT MICROLEAKS FROM POSITIVE SAMPLES COULD POTENTIALLY INTRODUCE INTERNAL CONTAMINATES. THE FALSE POSITIVE RATES OBSERVED ARE WITHIN THE CLAIMS OF THE IFU.
Additional Manufacturer Narrative
THE SERIAL NUMBER OF THE ANALYZER IS (B)(6). INVESTIGATION IS ONGOING.
Description of Event or Problem
THERE WAS AN ALLEGATION OF QUESTIONABLE RESULTS FOR A SINGLE PATIENT SAMPLE TESTED ON THE COBAS® INFLUENZA A/B & RSV NUCLEIC ACID TEST FOR USE ON THE COBAS® LIAT® SYSTEM. THE ALLEGED SAMPLE INITIALLY GENERATED A POSITIVE RESULT ON THE COBAS® LIAT ANALYZER. THE RETESTED SAMPLE GENERATED A NEGATIVE RESULT ON A DIFFERENT INSTRUMENT.