ABBOTT DIAGNOSTICS SCARBOROUGH, INC. ID NOW COVID-19 2.0 TEST KIT 24T (EUA); REAGENTS, 2019-NOVEL CORONAVIRUS NUCLEIC ACID
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Catalog Number 192-000 |
Device Problem
Unable to Obtain Readings (1516)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 01/01/2023 |
Event Type
malfunction
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Event Description
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The customer reported an unknown number of invalid results with the id now covid-19 2.0 performed on an unknown date.Repeat testing was performed on an unknown date generating invalid results.Confirmation testing was not performed.The customer reported the patient experienced a delay in surgery due to the test results.Although requested, no additional patient information including the type of surgery that was delayed, treatment and outcome, was provided.
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Manufacturer Narrative
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The event date provided is an estimate as the exact date of occurrence was not provided.The remainder of the investigation remains in progress.A supplemental report will be provided after completion.Single use, device discarded.
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Manufacturer Narrative
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The date provided in b3 is an estimate as the exact date of occurrence was not provided.Testing was performed at abbott diagnostics scarborough, inc.On retained kit lot 1092567 with internal positive quality control samples and negative quality control swabs.All test results were valid and performed as expected.Additionally, the manufacturing records and quality control release testing was reviewed for test kit part number 192-000/ lot: 1092567, test base part number 192-430/ lot: 1092567.The lot met the required release specifications.A review of the complaints reported as invalid patient results (confirmed and unconfirmed, conflicting results) related to kit lot 1092567 showed that the complaint rate is (b)(4).Abbott diagnostics scarborough, inc.Was unable to determine the exact root cause of the reported issue; however, a possible assignable root cause is patient sample interference.H3 other text : single use, device discarded.
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Event Description
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The customer reported an unknown number of invalid results with the id now covid-19 2.0 performed on an unknown date.Repeat testing was performed on an unknown date generating invalid results.Confirmation testing was not performed.The customer reported the patient experienced a delay in surgery due to the test results.Although requested, no additional patient information including the type of surgery that was delayed, treatment and outcome, was provided.
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