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This case involves an (b)(6) male in the (b)(6) with copd, atrial fibrillation, an indwelling urinary catheter, recurrent falls leading to hospitalizations and several other comorbid conditions who initially presented to (b)(6) hospital on (b)(6) 2020 with a fall, lymphopenia, elevated crp, and who was detected to have both influenza b and sars-cov-2 present in the nasopharynx using liat.Of note, subsequent analysis of this liat result by roche shows abnormal growth curves and likely false positive detection of both influenza b and sars-cov-2.However, as a result of the positive liat test result for sars-cov-2, this patient was cohorted with other covid-19 positive patients.The patient was then treated for copd exacerbation (possibly with nebulizers with aerosolizing potential), bacterial infection (with antibiotics) and covid-19 (including the administration of remdesivir, oxygen, and steroids).The patient presumably clinically improved as he was discharged several days later on (b)(6) 2021.One week later (on (b)(6) 2021), this patient was readmitted after another fall and possibly hypotensive episodes and again cohorted with other covid-positive patients given presumed recent covid-19 infection on prior admission one week prior.Initial covid-19 testing on admission yielded negative sars-cov-2 detection (altona platform); however, testing with a roche platform test on (b)(6) 2021 (6 days later) yielded a positive test for sars-cov-2.Despite treatment with oxygen, antibiotics, and presumably other interventions, this patient expired on (b)(6) 2021 from primary diagnoses of bronchopneumonia and copd.The following medical assessment was provided: based on internal analysis, this case involves the false detection of both influenza b and sars-cov-2 on the liat platform.The allegation from the customer suggests that the false detection of sars-cov-2, specifically, may have contributed to the death of this patient due to subsequent decisions (based on this test result) to cohort the patient with other covid-19 positive patients during the initial and a subsequent hospital stay.According to our internal medical opinion document, for a false positive sars-cov-2 result: "individuals erroneously diagnosed with covid-19 may be subjected to targeted therapies for covid-19 with life-threatening side effects to bodily organs.A false-positive may lead to life-threatening deviations from standard clinical management algorithms.Additionally, individuals may be cohorted with others who have sars- cov-2 infection and may contract the infection from them and suffer life threatening consequences or death." the probability of death in such a scenario has been determined to be rare with sporadic but not systematic occurrence.Therefore, it is possible for a non-infected patient to acquire a life-threatening covid-19 infection if mistakenly cohorted with other infected patients.In this case, in order for the false positive liat sars-cov-2 result to have indirectly contributed to this patients death, several events need to have occurred.First, the patient must not have been infected with covid-19 on the initial hospital admission.Second, the patient contracted covid-19 as a direct consequence of being cohorted with other covid-19 patients in the hospital.And third, the covid-19 infection was the contributary cause of death.Several factors need to therefore be considered to better understand the probability of harm in this specific case.First, it is possible that the patient may have indeed had a true covid-19 infection upon arrival to the hospital for the initial admission.The liat yielded an erroneous result (although undetectable to the user) but to our knowledge no other testing was performed for covid-19 during the initial hospital admission.Therefore, it is possible that the patient was infected to begin with although this appears to be less likely the case.Second, if we assume that the patient was non-infected on admission and then subsequently contracted a covid-19 infection, there are many potential mechanisms for exposure.The patient may have directly contracted the infection from other covid-19 positive individuals inside or outside the cohort area through aerosolization if nebulizers were administered for copd or if ventilation systems were not enough to limit spread.The patient may also have been exposed by other healthcare workers anywhere in the hospital, inside or outside of the cohort area (e.G., emergency room, hallways, etc.).And finally, the patient may have contracted covid-19 in between hospital admissions while outside of the hospital.The cohorting of this patient with other covid-19 positive patients may or may not have been the critical factor that led to the exposure to sars-cov-2.And finally, this patient appears to have been treated for non-covid-19 related conditions such as copd and bacterial infections (receiving antibiotics during both hospital stays).It is possible that the primary cause of death was not covid-19 but rather some other medical condition.Based on the information provided, the patient had a first true positive covid-19 positive result on (b)(6) 2021, which was over two weeks after the initial presentation and one week into the second hospital stay.Two previous falls lead to two separate hospital admissions (the first with a false positive sars-cov-2 on admission and the second with a negative covid-19 test on admission).Therefore, it seems plausible that the patient was suffering from life-threatening conditions other than covid-19 infection.All together, while it is possible that the false positive liat sars-cov-2 result may have indirectly contributed to the death of this patient, the cumulative probability of this happening seems very low considering the specific factors involved in this allegation.Consideration needs to be given to many other equally plausible non-covid-19 related medical causes of death and/or sources of exposure to sars-cov-2 that are not related to the initially obtained liat test results an investigation to evaluate the customer issue is ongoing.A review of the data identified inefficient pcr leading to a late ct value and/or low amplification.A request has been made to return analyzer 13555 for further investigation.The customer issue has been alleged on the cobas liat system, product code: occ, catalog number 07341920190 and udi (b)(4).The test used on the cobas liat system is the cobas sars-cov-2 & influenza a/b test for use on the cobas liat system (eua(b)(4), product code: qjr).The product catalog number for the test is 09211101190 and the udi is (b)(4).(b)(4).
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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 agencys instruction, we hereby submit this mdr.A customer alleged a high rate of invalids while using the cobas¿ sars-cov-2 & influenza a/b nucleic acid test for use on the cobas¿ liat¿ system.During the investigation of the invalid results, roche reviewed the data files and identified, on (b)(6) 2021, a potential false positive result for sars cov-2 and flu b targets generated on (b)(6) 2020.On (b)(6) 2020, the customer informed roche that the patient in question had expired.The patient is an (b)(6) male who was admitted to the emergency department after a fall on (b)(6) 2020.According to the customer, the patient was initially asymptomatic but tested positive for sars-cov-2 and was admitted to the covid-19 patient ward.After receiving treatment, he was discharged on (b)(6) 2021.On (b)(6) 2021 the patient was readmitted following another fall and sent back to the covid-19 patient ward (as he recently tested positive).Admission testing on (b)(6) 2021 with a non-roche assay generated a negative result.Repeat testing with the roche platform on (b)(6) 2021 was positive for sars-cov-2.From (b)(6) 2021 the patient continuing receiving increased oxygen and then on the (b)(6) was started on a new medication.On (b)(6) 2021 the patient expired.Provisional cause of death was put down as 1a bronchopneumonia, 1b copd, ii dementia, frailty.No information regarding sample collection or customer workflow is currently available.An investigation to evaluate the customer issue is ongoing.A review of the data identified inefficient pcr leading to a late ct value and/or low amplification.A request has been made to return analyzer 13555 for further inspection.A follow-up report will be filed when the outcome of the investigation becomes available.
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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.(b)(4).
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