MAUDE Adverse Event Report: ABBOTT GMBH ALINITY I SYPHILIS TP REAGENT KIT; ENZYME LINKED IMMUNOABSORPTION ASSAY, TREPONEMA PALLIDUM

Catalog Number 07P60-77

Device Problem False Negative Result (1225)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 11/13/2022

Event Type  malfunction  

Manufacturer Narrative

An evaluation is in process.A final report will be submitted when the evaluation is complete.Patient identifier complete entry = (b)(6).Facility name complete entry = (b)(6).Phone number complete entry = (b)(6).All available patient information was included.Additional patient details are not available.  this report is being filed on an international product, list number (b)(4) has a similar product distributed in the us, list number (b)(4).

Event Description

The customer observed false non-reactive alinity i syphilis tp result for a (b)(6)-year-old female patient.The following data was provided (reference range >1.0 s/co is reactive): sample id (b)(6) initial result = 0.07 s/co (nonreactive), repeat = 0.07 s/co, tppa result = positive, rpr result = 1.128 s/co (reactive).No impact to patient management was reported.

Manufacturer Narrative

The complaint investigation for false nonreactive alinity i syphilis tp result included a review of data and information provided by the customer, search for similar complaints, ticket trending review, labeling review, device history review, in house testing of a retained reagent kit, and return sample testing was completed.Trending review did not identify any trends for the issue for the product.Device history record review did not identify any non-conformances or deviations with lot 37020be01 and the complaint issue.In-house testing of a retained reagent kit of the complaint lot was performed.All controls met specifications and no false non-reactive results were obtained, indicating that the lot generates the expected results.Labeling was reviewed and sufficiently addresses the customer's issue.The returned specimen sample was tested with the following results: alinity i syphilis tp: 0.09 s/co (non-reactive), recomline treponema igm: negative, recomline treponema igg: negative.Testing of the return sample was performed with alinity i syphilis tp lot 41058be01, due to the complaint lot 37020be01 not being available for testing in the abbott shanghai laboratory.This reagent lot results were non-reactive, showing that the issue is not lot specific.In-house testing of a retained kit of reagent lot 37020be01 was performed.All specifications were met, and no false reactive results were obtained, showing that the lot generates the expected results.No discrepant results were generated.Based on the investigation, no systemic issue or deficiency with the alinity i syphilis tp reagent lot 37020be01 was identified.

• Brand Name: ALINITY I SYPHILIS TP REAGENT KIT
• Type of Device: ENZYME LINKED IMMUNOABSORPTION ASSAY, TREPONEMA PALLIDUM
• Manufacturer (Section D): ABBOTT GMBH; max-planck-ring 2; wiesbaden 65205 ; GM 65205
• Manufacturer (Section G): ABBOTT GMBH; max-planck-ring 2; wiesbaden 65205 ; GM 65205
• Manufacturer Contact: siobhan wright ; lisnamuck; post market surveillance; longford N39 E-932 ; EI N39 E932 ; 433331157
• MDR Report Key: 15872757
• MDR Text Key: 307721706
• Report Number: 3002809144-2022-00415
• Device Sequence Number: 1
• Product Code: LIP
• Combination Product (y/n): N
• Reporter Country Code: CH
• PMA/PMN Number: K153730
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 12/08/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/28/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 01/21/2023
• Device Catalogue Number: 07P60-77
• Device Lot Number: 37020BE01
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 11/30/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 02/24/2022
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: ALNTY I PROCESSING MODU, 03R65-01, (B)(6) ; ALNTY I PROCESSING MODU, 03R65-01, (B)(6)
• Patient Age: 59 YR
• Patient Sex: Female