ROCHE MOLECULAR SYSTEMS, INC. - BRANCHBURG COBAS® LIAT® 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); 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 12/06/2021 |
Event Type
malfunction
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Manufacturer Narrative
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A review of the data and curves does not show any abnormalities; this appears to be a true, low level positive sample.As the discrepant result occurred with another assay, it is possible that the sensitivity, as well as the detection technologies of the assays, are not comparable.(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 (b)(6) alleged discrepant results generated while using the cobas® sars-cov-2 & influenza a/b nucleic acid test on the cobas® liat® system.The customer reported that on (b)(6) 2021 run #746 generated a sars-cov-2 positive result when tested and analyzed on the cobas® liat® system (s/n (b)(4)).The patient¿s same sample was repeat tested using a different platform (cobas) that generated a sars-cov-2 negative result.The patient¿s same sample was repeat 8 hours later (run #748) and analyzed again on the cobas® liat® system (s/n (b)(4)) that generated a sars-cov-2 positive result.The customer is using a biocomma sample collection kit which is off-label.As per the method sheet, collect specimen using a sterile flocked swab with a synthetic tip according to applicable manufacturer instructions and/or standard collection technique using 3 ml of viral transport media or sterile 0.9% physiological saline.The customer confirmed there was no allegation of harm to the patient.The positive and negative results were reported out to the patient and/or personnel treating the patient.
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Search Alerts/Recalls
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