Catalog Number 256082 |
Device Problem
Incorrect, Inadequate or Imprecise Result or Readings (1535)
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Patient Problems
Virus (2136); No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 09/11/2020 |
Event Type
malfunction
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Manufacturer Narrative
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Eua # (b)(4).Medical device expiration date: unknown.A device evaluation is anticipated, but has not yet begun.Upon completion of the investigation, a supplemental report will be filed.Device manufacture date: unknown.(b)(4).
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Event Description
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It was reported while using bd rapid detection of sars-cov-2 veritor assay false positive results were obtained by the laboratory personnel.The samples were repeated on the veritor 3 more times and all were positive.Patient was moved to covid floor of facility.Pcr testing came back negative, however now patient is covid positive after being moved to covid floor.Eua # (b)(4).
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Manufacturer Narrative
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The following fields have been updated with additional information received: d.4.Medical device lot #: 0220968; d.4.Medical device expiration date: 2020-12-17; h.4.Device manufacture date: 2020-08-21.
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Event Description
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It was reported while using bd rapid detection of sars-cov-2 veritor assay false positive results were obtained by the laboratory personnel.The samples were repeated on the veritor 3 more times and all were positive.Patient was moved to covid floor of facility.Pcr testing came back negative, however now patient is covid positive after being moved to covid floor.Eua # 201889.
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Event Description
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It was reported while using bd rapid detection of sars-cov-2 veritor assay false positive results were obtained by the laboratory personnel.The samples were repeated on the veritor 3 more times and all were positive.Patient was moved to covid floor of facility.Pcr testing came back negative, however now patient is covid positive after being moved to covid floor.Eua # (b)(4).
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Manufacturer Narrative
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Eua#: (b)(4).H6: investigation summary bd has received several customer complaints for false positive results, when using bd sars-cov-2 reagents for bd veritor¿ system.The current investigation concerns multiple lots of bd sars-cov-2 reagents for bd veritor¿ system.Bd takes a systematic approach to investigating false positive complaints that are received.This approach involves review of manufacturing batch history records, testing of retention samples, and testing of customer returned samples if applicable.Retain samples were tested for batch #: 0220968.The defect could not be replicated and therefore the complaint could not be confirmed.A device history review was conducted for lot number0220968.The investigation did not find a root cause for the false positive results that were observed.It is recommended that each customer review their workflow carefully to ensure that the package insert is being followed as written.The root cause is under investigation and will be documented in our quality system.Bd cannot confirm the complaint based on the investigation that was performed.A corrective and preventive action (capa#1878253) is already initiated to investigate the root cause and some mitigation actions are already being addressed.H3 other text : see h10.
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Search Alerts/Recalls
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