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
False Positive Result (1227); Incorrect, Inadequate or Imprecise Result or Readings (1535)
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Patient Problems
Anxiety (2328); Unspecified Respiratory Problem (4464); No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 05/14/2022 |
Event Type
malfunction
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Manufacturer Narrative
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Roche received complaints alleging invalid and/or false positive results with the cobas® sars-cov-2 & influenza a/b test for use on the cobas® liat® system for one or more targets (sars-cov-2, influenza a, influenza b).When reviewing the customer-provided data associated with the reported invalid and false positive results, abnormal pcr curves were observed.Per the on-going investigation, several potential causes for the abnormal pcr growth curves leading to invalids and false positives have been identified.These include tube leaks, abnormal pcr steps, and loose thermal sensor wiring.Overall across the installed base, these issues from product use may occur sporadically.For invalid or false positive influenza results, adverse health consequences are not likely.For invalid sars-cov-2, adverse health consequences are not likely since detectability is high and testing can be performed on alternative platforms.For erroneous positive sars-cov-2 results, there is the possibility of adverse health consequences in high risk individuals.As stated in the instructions for use, clinical correlation with patient history and other diagnostic information is necessary to determine patient infection status.A cobas liat software update to better identify the thermal sensor errors and a new cobas® sars-cov-2 & influenza a/b script to better detect abnormal pcr curves have been launched.The implementation of both the software and the updated script have shown a reduction in the calculated false positive rate.Consignees have been notified.(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 alleged discrepant results when using the cobas sars-cov-2 & influenza a/b test for use on the cobas liat system.The initially alleged sample in run # (b)(6) tested sars-cov-2 positive, influenza a positive, and influenza b positive.The same sample was repeated with the same device as negative for all 3 targets.A further repeat of a recollected sample with the genexpert assay was also negative.Upon further review of the data provided, two additional runs were identified; run #(b)(6) generated a potential false positive for influenza b target, and run #173 generated a potential false positive for influenza b and sars-cov-2 targets.It is unknown if these samples were repeated.The results were not reported to the patient and or/ medical personnel treating the patient.No apparent harm or injury occurred in relation to the event.An investigation was conducted to evaluate the customer¿s allegation.Per fda¿s eua guidance, 3 mdrs will be filed.
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