ROCHE MOLECULAR SYSTEMS, INC. - BRANCHBURG COBAS SARS-COV-2 & INFLUENZA A/B TEST FOR USE ON THE COBAS LIAT SYSTEM; REAGENTS, 2019-NOVEL CORONAVIRUS NUCLEIC ACID
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Catalog Number 09211101190 |
Device Problems
False Positive Result (1227); Energy Output Problem (1431); Incorrect, Inadequate or Imprecise Result or Readings (1535); Output Problem (3005)
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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 02/07/2021 |
Event Type
malfunction
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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 a false positive for a single patient while using the cobas® sars-cov-2 & influenza a/b nucleic acid test for use on the cobas® liat® system.The patient sample originally generated a positive result for sars-cov-2, flu a and flu b.The sample was retested and released as negative.No harm was alleged.No information is currently available regarding sample collection or customer workflow.An investigation to evaluate the customer issue is ongoing.
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Manufacturer Narrative
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(b)(6).A customer alleged a false positive for a single patient while using the cobas® sars-cov-2 & influenza a/b nucleic acid test for use on the cobas® liat® system.The patient sample originally generated a positive result for sars-cov-2, flu a and flu b but upon repeat, generated negative results.No harm was alleged.An investigation to evaluate the customer issue is ongoing.(b)(4).
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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 and a new cobas® sars-cov-2 & influenza a/b script to better identify errors and detect abnormal pcr curves will be made available in due course.Consignees have been notified.
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Search Alerts/Recalls
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