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 03/26/2024

Event Type  malfunction  

Manufacturer Narrative

All available patient information was included.Additional patient details are not provided.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 negative alinity i syphilis results generated on an alinity i processing module for one patient in the icu being treated for a lung infection when compared to other methods.The following information was provided: on (b)(6) 2024 initial result = 1.13, repeat results = 1.15 and 1.13, tppa positive, colloidal gold positive, rpr negative on (b)(6) 2024 initial result = 0.97, repeat results = 0.96 and 0.95, tppa positive, colloidal gold positive, rpr negative there was no impact to patient management.

Manufacturer Narrative

The complaint investigation included a review of data and information provided by the customer, search for similar complaints, ticket trending review, labeling review, device history record, and in house testing of a retained reagent kit.Return testing was not completed as returns were not available.Data and information provided by the customer were reviewed and support the complaint issue without indication for any additional issue.Ticket search by lot shows slightly higher complaint activity; however, no trends were identified.Ticket trending review did not identify any trends.Device history record review did not identify any non-conformances or deviations with the complaint lot number and issue.In house testing of a retained reagent kit lot 55063be01 was performed.All specifications were met with no false non-reactive results obtained, showing the lot generates the expected results.Labeling was reviewed and found to adequately address the issue under review.Based on the investigation, no systemic issue or deficiency with the alinity i syphilis tp reagent lot 55063be01 was identified.

Event Description

The customer observed false negative alinity i syphilis results generated on an alinity i processing module for one patient in the icu being treated for a lung infection when compared to other methods.The following information was provided: (b)(6) 2024 initial result = 1.13, repeat results = 1.15 and 1.13, tppa positive, colloidal gold positive, rpr negative.(b)(6) 2024 initial result = 0.97, repeat results = 0.96 and 0.95, tppa positive, colloidal gold positive, rpr negative.There was no impact to patient management.

• 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: 19044079
• MDR Text Key: 339782322
• Report Number: 3002809144-2024-00093
• 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: 04/29/2024

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: 03/27/2024
• Initial Date FDA Received: 04/04/2024
• Supplement Dates Manufacturer Received: 04/24/2024
• Supplement Dates FDA Received: 04/29/2024
• 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)