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 03/13/2024

Event Type  malfunction  

Manufacturer Narrative

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 7p60-77 that has a similar product distributed in the us, list number 07p60-21 / 31.All available patient information was included.Additional patient details are not available.

Event Description

The customer observed falsely non-reactive alinity i syphilis tp results for one sample.The following information was provided: initial result was 0.66 s/co, repeat result was 0.73 s/co roche result was 1.42 (reference range 0-1), rpr was positive no impact to patient management was reported.

Manufacturer Narrative

Updated information in section d4 primary udi number.The complaint investigation for falsely non-reactive 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, and in house testing.Review of all the information provided by the customer was reviewed.The ticket search by lot indicates that the reagent lot performs as expected for this product.A review of tracking and trending did not identify any trends for the complaint issue.Device history record review did not show any deviations or non-conformances associated with the likely cause lot number(s) and complaint issue.In-house testing was completed using an in-house retained kit.All specifications were met and no false non-reactive results were obtained, showing that the lot generates the expected results.Based on the investigation, no systemic issue or deficiency of the alinity i syphilis tp for lot number 55063be01 was identified.All available patient information was included.Additional patient details are not available.

Event Description

The customer observed falsely non-reactive alinity i syphilis tp results for one sample.The following information was provided: initial result was 0.66 s/co, repeat result was 0.73 s/co.Roche result was 1.42 (reference range 0-1), rpr was positive.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: 18935561
• MDR Text Key: 338304946
• Report Number: 3002809144-2024-00078
• Device Sequence Number: 1
• Product Code: LIP
• UDI-Device Identifier: 00380740162009
• UDI-Public: (01)00380740162009(17)240727(10)55063BE01
• 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: 04/11/2024

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 Catalogue Number: 07P60-77
• Device Lot Number: 55063BE01
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 03/14/2024
• Initial Date FDA Received: 03/19/2024
• Supplement Dates Manufacturer Received: 04/11/2024
• Supplement Dates FDA Received: 04/11/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 09/04/2023
• 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)