ROCHE MOLECULAR SYSTEMS, INC. - BRANCHBURG COBAS® SARS-COV-2 & INFLUENZA A/B; COVID-19 MULTI-ANALYTE RESPIRATORY PANEL NUCLEIC ACID DEVICES
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Catalog Number 09211101190 |
Device Problems
Incorrect, Inadequate or Imprecise Result or Readings (1535); Non Reproducible Results (4029)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 03/10/2023 |
Event Type
malfunction
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Manufacturer Narrative
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For the march 10th run (run #7313) which generated a positive result for sars-cov-2 and influenza b, the ct values and amp values generated for both targets are fairly late and low, indicating likely a low-level positive sample.Very low viral load specimens that are near the assay limit of detection (lod) may not generate consistent results upon repeat testing according to expected statistical variances in detection.No other abnormalities were observed with the alleged runs; the performance of the analyzer, though with limited runs, appears steady.Though rare, dual infections can occur.For the march 16th run (run# 3378) investigation is still ongoing.A follow-up report will be filed upon the completion of the investigation.
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Event Description
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In light of the covid-19 pandemic and the subsequent emergency use authorizations (euas) for sars-cov-2 diagnostic tests, the agency has requested heightened reporting beyond the reasonably suggests requirements of 803 to include allegations of false positive or false negative results independent of harm or malfunction or off-label use.Pursuant to the agency¿s instruction, we hereby submit this mdr.A customer from austria alleged a discrepant result for a single patient while using the cobas® sars-cov-2 & influenza a/b nucleic acid test on the cobas® liat® system.The alleged sample initially generated a positive result for sars-cov-2 and influenza b when tested on cobas liat.The same sample was tested on a competitor platform (alinity m (4plex)) and was negative.A new sample was collected and tested on cobas liat which generated a triple positive result (sars-cov-2, influenza a and b).The same sample was tested on two competitor platforms (qiastat-dx analyzer qiagen (sars-cov-2/flu a/b/rsv panel) and alinity m (4plex)) which generated negative results.The negative results were reported.No harm was alleged.Per fda¿s eua guidance, 1 mdr will be filed.
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Manufacturer Narrative
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The customer¿s allegation of discrepant results, could not be reproduced in the investigation.The assay is performing within its clinically-validated claims.Potential causes of the observed discrepant results include, but are not limited to the following: ¿ contamination or non-specific amplification: cross-contamination during sample prep could introduce the target into a negative sample.In some cases, sample interferences/contaminants could cause amplification of something other than the target.¿ sample mix-up.¿ differences in technology.----------- device code was updated to non reproducible results.
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Search Alerts/Recalls
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