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 01/23/2024

Event Type  malfunction  

Manufacturer Narrative

Complete information for section a patient information, 1.Patient identifier = sid= (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 07p60-77, that has a similar product distributed in the us, list number 07p60-21 / 31.

Event Description

The customer observed false nonreactive architect syphilis tp results that does not match with tppa on one 39yrs old female pregnant female patient.The results provided were: sid (b)(6) initial=0.04 s/co (< 1.00 s/co=nonreactive) /tppa at another hospital=1:160 (positive) /at another hospital on mairay cl6000i=0.06 s/co there was no reported impact to patient management.

Event Description

The customer observed false nonreactive architect syphilis tp results that does not match with tppa on one 39yrs old female pregnant female patient.The results provided were: sid (b)(6)initial=0.04 s/co (< 1.00 s/co=nonreactive) /tppa at another hospital=1:160 (positive) /at another hospital on mairay cl6000i=0.06 s/co there was no reported impact to patient management.

Manufacturer Narrative

The complaint evaluation 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 of alinity i syphilis tp reagent lot 52340be01.A review of tracking and trending data did not identify any related trends for the product for the issue.Return testing was not completed as returns were not available.The ticket search by lot indicates that the reagent lot performs as expected for this product.Device history record review did not identify any non-conformances or deviations with the complaint lot and complaint issue.In-house testing of retained reagent kits of the complaint lot was performed.All specifications were met and no false non-reactive results were obtained, showing that the lot generates the expected results.A review of the manufacturing documentation did not identify any issues associated with the customer¿s observation.There was no issue with reagent performance identified.A review of the product labeling concluded that the issue is sufficiently addressed.Based on the investigation no product deficiency was identified for the alinity i syphilis tp reagent lot 52340be01.

• 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: 18615983
• MDR Text Key: 334262187
• Report Number: 3002809144-2024-00025
• 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: 03/07/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/31/2024
• 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: 52340BE01
• 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: 06/22/2023
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Treatment: ALNTY I PROCESSING MODU, 03R65-01, (B)(6); ALNTY I PROCESSING MODU, 03R65-01, (B)(6)
• Patient Age: 39 YR
• Patient Sex: Female