ABBOTT GMBH ALINITY I SYPHILIS TP REAGENT KIT; ENZYME LINKED IMMUNOABSORPTION ASSAY, TREPONEMA PALLIDUM
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Catalog Number 07P60-32 |
Device Problem
False Positive Result (1227)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 09/23/2022 |
Event Type
malfunction
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Manufacturer Narrative
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This report is being filed on an international product, list number 7p60-32 and there is a similar product distributed in the us, list number 07p60-21 / 31.E1 phone: complete phone number is (b)(6).All available patient information was included.Additional patient details are not available.An evaluation is in process.A follow-up report will be submitted when the evaluation is complete.
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Event Description
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The customer obtained non-reactive alinity i syphilis tp for 1 patient, and is stating that the results were not consistent with patient¿s history.The customer provided the following data (reference < 1.0 s/co is non-reactive).(b)(6) 2022 ¿ syphilis result was 0.82 (non-reactive), generated from reagent lot 38426be00, tested on alinity ai21520.Historical syphilis results: (b)(6) 2018 ¿ syphilis: reactive 11.62 s/co (abbott architect platform), vdrl: reactive.(b)(6) 2019 ¿ syphilis: reactive (siemens platform), vdrl: non-reactive.(b)(6) 2020 ¿ syphilis: reactive (siemens platform), vdrl: non-reactive.(b)(6) 2020 ¿ syphilis: reactive (siemens platform), vdrl: non-reactive there was no reported impact to patient management.
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Manufacturer Narrative
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The complaint investigation included a review of data and information provided by the customer, search for similar complaints, ticket trending review, labeling review, device history record review, and in house testing.Return testing was not completed as returns were not available.Data and information provided by the customer were reviewed and support the complaint issue without indication for any additional issue.Device history review did not identify any non-conformances or deviations with the complaint lot.The ticket search by lot indicates that the reagent lot 38426be00 perform as expected for this product.Ticket and trending review did not identify any related trends regarding commonalities for complaint lot numbers and customer issue.In-house testing was conducted on lot number 38426be01, which contains the same bulk material as, lot number 38426be00, and concluded which determined that all controls met specifications and no false non-reactive results were obtained.In house testing concluded that the expected results were generated.Labeling was reviewed and was found to address the customer reported issue.Based on the investigation, no systemic issue or deficiency was identified for alinity i syphilis tp reagent, lot number 38426be00.
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Event Description
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The customer obtained non-reactive alinity i syphilis tp for 1 patient, and is stating that the results were not consistent with patient¿s history.The customer provided the following data (reference < 1.0 s/co is non-reactive).(b)(6) 2022 ¿ syphilis result was 0.82 (non-reactive), generated from reagent lot 38426be00, tested on alinity ai21520.Historical syphilis results: (b)(6) 2018 ¿ syphilis: reactive 11.62 s/co (abbott architect platform), vdrl: reactive.(b)(6) 2019 ¿ syphilis: reactive (siemens platform), vdrl: non-reactive.(b)(6) 2020 ¿ syphilis: reactive (siemens platform), vdrl: non-reactive.(b)(6) 2020 ¿ syphilis: reactive (siemens platform), vdrl: non-reactive there was no reported impact to patient management.
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Manufacturer Narrative
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Section h6 - adverse event problem, type of investigation coding was corrected.
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Event Description
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The customer obtained non-reactive alinity i syphilis tp for 1 patient, and is stating that the results were not consistent with patient¿s history.The customer provided the following data (reference < 1.0 s/co is non-reactive).(b)(6) 2022 ¿ syphilis result was 0.82 (non-reactive), generated from reagent lot 38426be00, tested on alinity (b)(6).Historical syphilis results: (b)(6) 2018 ¿ syphilis: reactive 11.62 s/co (abbott architect platform), vdrl: reactive (b)(6) 2019 ¿ syphilis: reactive (siemens platform), vdrl: non-reactive (b)(6) 2020 ¿ syphilis: reactive (siemens platform), vdrl: non-reactive (b)(6) 2020 ¿ syphilis: reactive (siemens platform), vdrl: non-reactive there was no reported impact to patient management.
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