ABBOTT DIAGNOSTICS SCARBOROUGH, INC. ID NOW COVID-19 ASSAY; MOLECULAR IVD FOR ID NOW COVID-19,
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Catalog Number 190-000 |
Device Problem
Use of Device Problem (1670)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Type
malfunction
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Manufacturer Narrative
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The investigation is still in progress.A supplemental report will be provided after completion.
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Event Description
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The customer reported a conflicting result with the id now covid-19 assay performed on a nasopharyngeal sample using a flocked tip swab and generated a positive result.The customer reported that the er patient was retested using the id now covid-19 assay and obtained a negative result.The customer confirmed there was no patient harm due to the test results.Additionally, the customer confirmed there was no delay or impact in the patient's treatment.
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Manufacturer Narrative
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This supplemental report is being submitted to provide additional information from the customer the reported.Please see updates: g3, g6 and h2.Additional information from the customer states a direct swab was used with no vtms.The sample type, dates and times of the repeat test were as followed: * direct swab used date and time meter result.* initial test (b)(6) 2021, 20:31 instrument sn: (b)(6) positive.* repeat (b)(6) 2021, 23:17 instrument sn: (b)(6) negative.* 2nd repeat (b)(6) 2021, 23:30 instrument sn: (b)(6) negative.
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Manufacturer Narrative
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This supplemental report is being submitted to provide the investigation conclusion.Please see updates: g3, g6 and h2.Correction for mfr.Report number from 1221359-2022-00001 to 1221359-2022-00003.Testing was performed at abbott diagnostics scarborough, inc.On retained kit lot 1050746 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 191-000 / lot 1050746 and test base part number 190-430 / lot 1050746.The lot met the required release specifications.A review of the complaints reported as false positive patient results (confirmed and unconfirmed, conflicting results) related to kit lot 1050746 showed that the complaint rate is (b)(4).In addition, a review of the complaints reported as false negative patient results (confirmed and unconfirmed, conflicting results) related to kit lot 1050746 showed that the complaint rate is (b)(4).Based on manufacturing batch record review, lot trace tracking and trending, and retain testing with qc controls, the lot appears to be functioning as intended and no further action is required.
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