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 9211101190 |
Device Problems
Incorrect, Inadequate or Imprecise Result or Readings (1535); Output Problem (3005); Non Reproducible Results (4029)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 03/01/2022 |
Event Type
malfunction
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Manufacturer Narrative
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The most likely cause for the discrepancy observed may be sample specific and from lab cross-contamination.Also of note is the off-label collection kit in use.Throughout the data analysis, a systematic issue was not observed and a product problem was not found.Facility name: hong kong adventist hospital-(b)(6) rd 7/f,clinical laboratory, the facility's full name has been truncated due to character limitations.(b)(4).
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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 hong kong 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.The same sample was retested on a different cobas® liat® system and a different platform (genexpert).Both of those tests yielded negative results.The initial positive result was not released.No harm was alleged.An investigation was conducted to evaluate the customer issue.Per fda¿s eua guidance, 1 mdr will be filed.
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Search Alerts/Recalls
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