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 Problem
Incorrect, Inadequate or Imprecise Result or Readings (1535)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 02/13/2023 |
Event Type
malfunction
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Manufacturer Narrative
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Throughout the data analysis, a systematic issue was not observed and a product problem was not found.According to the data provided and reviewed, the instruments appear to be working well.The most likely cause for the discrepancy observed is due to the sample having a low viral load for sars-cov-2, where results are known to waiver on repeat testing.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.Cross-contamination cannot be ruled out.
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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 the united states 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 a.The same sample was retested on a separate cobat liat analyzer which generated a negative result for influenza b and sars-cov-2 and positive result for influenza a.The retest results were reported out (negative for influenza b and sars-cov-2, positive for influenza a).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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