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 03/22/2023 |
Event Type
malfunction
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Manufacturer Narrative
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An investigation is in progress.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 france alleged a discrepant result with a single patient 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 flu b (negative flu a and sars-cov-2).The same sample was repeated on a different cobas liat analyzer and generated a negative result for all targets (flu b/flu a and sars-cov-2).The same sample was repeated a second time using the cobas® influenza a/b & rsv nucleic acid test on the same cobas liat analyzer and generated a negative result for all targets (flu b, flu a, rsv).The positive result was not 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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