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

Catalog Number 07P60-32

Device Problem False Negative Result (1225)

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

Event Date 12/11/2023

Event Type  malfunction  

Manufacturer Narrative

Completed information for section a1 patient identifier: (b)(6).An evaluation is in process.A follow-up report will be submitted when the evaluation is complete.This report is being filed on an international product, list number 7p60-32 has a similar product distributed in the us, list number 7p60-21/-31.

Event Description

The customer observed false nonreactive alinity i syphilis tp results for a 29 year old male patient.The following data was provided: (b)(6) 2023 sid (b)(6) initial result (ai21520) = 0.96 s/co, repeat (ai21516) = 0.93 s/co, rapid test = reactive, vdrl = nonreactive.Previous results: (b)(6) 2019: siemens result = 4.39 s/co, rapid test = reactive, vdrl = nonreactive.(b)(6) 2021 sid (b)(6) alinity result = 1.57 s/co.(b)(6) 2023 sid (b)(6) alinity result = 1.02 s/co.No impact to patient management was reported.

Manufacturer Narrative

The complaint investigation for the alinity i syphilis reagent included a review of data and information provided by the customer, search for similar complaints, ticket trending review, device history record review, and labeling review.Additionally, in-house testing was completed.Return testing was not completed as returns were not yet available.Data and information provided by the customer were reviewed and support the complaint issue without indication for any additional issue.A search for similar complaints did not identify an increase in complaint activity for lot 50282be00.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 associated with lot 50282be00 and the complaint issue.Labeling was reviewed and sufficiently addresses the customer¿s issue.In-house sensitivity testing was completed with a retained kit of lot 50281be00.All specifications were met, and no false non-reactive results were obtained, showing that the expected results were generated.Based on our investigation, no systemic issue or deficiency with the alinity i syphilis reagent for lot 50282be00 was identified.

Event Description

The customer observed false nonreactive alinity i syphilis tp results for a 29 year old male patient.The following data was provided: 11dec2023 sid (b)(6)initial result (ai21520) = 0.96 s/co, repeat (ai21516) = 0.93 s/co, rapid test = reactive, vdrl = nonreactive previous results: 14jan2019: siemens result = 4.39 s/co, rapid test = reactive, vdrl = nonreactive 17dec2021 sid (b)(6)alinity result = 1.57 s/co 02feb2023 sid (b)(6)alinity result = 1.02 s/co no impact to patient management was reported.

• 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: nicole jenne ; max-planck-ring 2; post market surveillance; wiesbaden 65205 ; GM 65205 ; 6122582960
• MDR Report Key: 18487999
• MDR Text Key: 332616942
• Report Number: 3002809144-2024-00009
• Device Sequence Number: 1
• Product Code: LIP
• Combination Product (y/n): N
• Reporter Country Code: BR
• 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: 03/06/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/10/2024
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 03/13/2024
• Device Catalogue Number: 07P60-32
• Device Lot Number: 50282BE00
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 03/05/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 04/20/2023
• 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); ALNTY I PROCESSING MODU, 03R65-01, (B)(6); ALNTY I PROCESSING MODU, 03R65-01, (B)(6)
• Patient Age: 29 YR
• Patient Sex: Male