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 04/02/2024

Event Type  malfunction  

Manufacturer Narrative

An evaluation is in process.A follow up report will be submitted when the evaluation is complete.There was no additional patient information provided.This report is being filed on an international product, list number 8d06-77 that has a similar product distributed in the us, list number 8d06-41.

Event Description

The customer reported a false nonreactive alinity i syphilis tp result on a female pregnant patient.Results provided: alinity = 0.06 s/co (nonreactive), repeat on alinity is also nonreactive; elisa and tpaa are both positive; trust and mindray platform were negative.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: 19164520
• MDR Text Key: 340906559
• Report Number: 3002809144-2024-00125
• Device Sequence Number: 1
• Product Code: LIP
• UDI-Device Identifier: 00380740162009
• UDI-Public: (01)00380740162009(17)240516(10)52340BE01
• 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
• Report Date: 04/23/2024

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 Expiration Date: 05/16/2024
• Device Catalogue Number: 07P60-77
• Device Lot Number: 52340BE01
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 04/03/2024
• Initial Date FDA Received: 04/23/2024
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 06/22/2023
• 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)
• Patient Sex: Female