The customer reported an increase of invalid results with the id now covid-19 assay for multiple patients over various dates.This mfr.Report is one (3) of four (4) and addresses invalids which occurred in (b)(6).The customer reported seventy-three (73) invalid results with the id now covid-19 assay on direct tested nasopharyngeal and nasal swabs (miraclean technology) for the month of (b)(6).Repeat testing also generated invalid results which resulted in a 1.5 hour delay as the sample had to be recollected for testing using the cepheid platform (results not provided).Per the customer, no patient harm occurred; however, the patients could not be admitted until the test results were back.Additionally, per the customer the delay impacted the entire hospital due to delays in freeing bed space.
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This supplemental report is being submitted to correct the lot number and to provide the investigation conclusion.The case provided two lot numbers (lot m159709 and lot 1034333).However, the customer did not specify which lot was used.The investigations for both lot numbers are being provided.Testing was performed at abbott diagnostics scarborough, inc.On retained kit lot m159709 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 number190-000 / lot m159709.Test base part number 190-430 / lot m159709.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 m159709 showed that the complaint rate (b)(4).The exipiration date: (lot m159709) 11/11/2021 and (lot 1034333) 11/09/2021.The manufacturer date: (lot m159709) 5/14/2021 and (lot 1034333) 5/17/2021.Testing was performed at abbott diagnostics scarborough, inc.On retained kit lot 1034333 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 190-000 / lot 1034333.Test base part number 190-430 / lot 1034333.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 1034333 showed that the complaint rate (b)(4).In conclusion, abbott diagnostics scarborough was unable to determine the exact root cause of the reported issue however a possible assignable root cause is sample interference.Abbott scarborough diagnostics was able to determine from the logfile that the majority of the invalid results were due to unknown sample interference.Substances in the sample itself may have interfered with the reaction.It was also observed that some of the invalids were also due to sample transfer errors.Based on the above summary, the investigation is deemed closed.The product will continue to be monitored and tracked.
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