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

Catalog Number 07P60-74

Device Problem False Negative Result (1225)

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

Event Date 09/06/2022

Event Type  malfunction  

Manufacturer Narrative

An evaluation is in process.A follow-up report will be submitted when the evaluation is complete.Initial reporter name and address: phone 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 07p60-22, that has a similar product distributed in the us, list number 07p60-21.

Event Description

The customer observed a false nonreactive alinity i syphilis tp result for four patients.The following data was provided (<1.00 s/co is nonreactive, >/=1.00 s/co is reactive): sample 1 result was 0.80 s/co, the elisa result was positive, and the mindray result was 2.02 s/co, which is positive sample 2 result was 0.88 s/co, the elisa result was positive, and the mindray result was 2.04 s/co, which is positive sample 3 result was 0.90 s/co, the elisa result was positive, and the mindray result was 2.06 s/co, which is positive sample 4 result was 0.63 s/co, the elisa result was positive, and the mindray result was 1.94 s/co, which is positive.There was no impact to patient management reported.

Manufacturer Narrative

This report is being filed on an international product, list number 07p60-74, that has a similar product distributed in the us, list number 07p60-21.The complaint investigation for false nonreactive alinity i syphilis tp results included a review of data and information provided by the customer, search for similar complaints, ticket trending review, labeling review, device history record review, testing of retained reagent kit of the complaint lot number, and return sample testing.Trending review determined no related trend for the issue for the product.Sensitivity testing was performed using an in-house retained kit of lot number 33222be01, stored at the recommended storage condition.All specifications were met, and no false reactive results were obtained, indicating that the sensitivity performance is not negatively impacted.The returned specimens were tested with the following results: sample id 1 alinity i syphilis tp was 0.39 s/co (non-reactive), recomline treponema igm was negative, recomline treponema igg was negative; sample id 2 alinity i syphilis tp was 0.63 s/co (non-reactive), recomline treponema igm was negative, recomline treponema igg was negative; sample id 3 alinity i syphilis tp was 0.65 s/co (non-reactive), recomline treponema igm was negative, recomline treponema igg was negative; sample id 4 alinity i syphilis tp was 0.99 s/co (non-reactive), recomline treponema igm was negative, recomline treponema igg was negative.Device history record review did not identify any non-conformances or deviations with the likely cause lot and complaint issue.Manufacturing documentation for the likely cause lot was reviewed and did not identify any issues.Labeling was reviewed and sufficiently addresses the customer's issue.Based on the information provided and abbott diagnostics¿ complaint investigation, no systemic issue or deficiency of alinity i syphilis tp, lot number 33222be01, was identified.D4 - catalog no updated from 07p60-22 to 07p60-74; d4 - lot no updated from 33222be00 to 33222be01.

• 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: 15513344
• MDR Text Key: 302674731
• Report Number: 3002809144-2022-00342
• 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: 11/30/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 09/15/2022
• Device Catalogue Number: 07P60-74
• Device Lot Number: 33222BE01
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 09/06/2022
• Initial Date FDA Received: 09/30/2022
• Supplement Dates Manufacturer Received: 11/16/2022
• Supplement Dates FDA Received: 11/30/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 10/08/2021
• 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)