Catalog Number 09448870190 |
Device Problems
False Positive Result (1227); Incorrect, Inadequate or Imprecise Result or Readings (1535); Output Problem (3005)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 09/28/2022 |
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 from austria alleged a discrepant sars-cov-2 result for a single patient while using the cobas sars-cov-2 qualitative nucleic acid test for use on the cobas 58/68/8800 systems.The alleged sample initially generated a target 1 (sars-cov-2) positive and target 2 (pan-sarbecovirus) negative results when tested on cobas 5800 system.The sample was retested on the cobas liat assay and the cobas 5800.1st retest: same sample was retested on the cobas liat generating negative results.2nd retest: same sample was retested on the cobas 5800 generating target 1 (sars-cov-2) positive and target 2 (pan-sarbecovirus) negative results.3rd retest: new sample was obtained and tested on the cobas liat generating negative results.It is unknown if the results were reported.No harm or injury is indicated.An investigation has been initiated and is ongoing.Per fda¿s eua guidance, 1 mdr will be filed.
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Manufacturer Narrative
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An investigation is in progress.A follow-up report will be filed upon the completion of the investigation.The customer issue has been alleged on the cobas sars-cov-2 qualitative test for use on the cobas 5800/6800/8800 systems ce-ivd, catalog number 09448870190 and udi (b)(4) which is not yet available in the us.The similar assay currently available in the us under emergency use authorization is the cobas sars-cov-2 test for use on the cobas 6800-8800 system (b)(4), product code: qjr).The product catalog number for the test (480t) is 09343733190 and the udi is (b)(4).Facility name truncated due to character limit: (b)(6).
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Manufacturer Narrative
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There is no indication the product is not performing as intended.The likely cause of the discrepancy is sample specific factors.The likely cause of the discrepancy alleged is that the sample alleged is near the lod.Samples near the lod can waiver between positive and negative.Other sample and site specific factors like contamination also cannot be ruled out as contributing factor.Updated b6 with the ct values, added that it is unknown if the recollected sample was tested on cobas 5800.Corrected target 1 and 2 results in b6 and b5 (from t1 positive and t2 negative to t1 negative and t2 positive for the testing performed on cobas 5800).
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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 austria alleged a discrepant sars-cov-2 result for a single patient while using the cobas sars-cov-2 qualitative nucleic acid test for use on the cobas 58/68/8800 systems.The alleged sample was tested twice on cobas 5800 and generated a positive result each time (target 1: sars-cov-2 = negative; target 2: pan-sarbecovirus = positive).The same sample and a newly collected samples were tested on cobas liat and generated a negative result each time.It is unknown if the results were reported.No harm or injury is indicated.An investigation has been initiated and is ongoing.Per fda¿s eua guidance, 1 mdr will be filed.
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Search Alerts/Recalls
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