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

Catalog Number 08D06-74

Device Problem False Negative Result (1225)

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

Event Date 10/20/2022

Event Type  malfunction  

Event Description

The customer reported false nonreactive architect syphilis tp results for a patient sample.The following data was provided (reference range: < 1.00 s/co nonreactive, >/= 1.00 s/co is reactive): sid (b)(6): initial result: 0.61 s/co (nonreactive); roche platform: positive (specific data was unknown); tppa result: positive; the patient¿s historical result was positive.There was no impact to patient management reported.

Manufacturer Narrative

All available patient information is included.Additional patient details are not available.This report is being filed on an international product, list number 08d06-74 that has a similar product distributed in the us, list number 8d06-31 / 41.An evaluation is in process.A follow-up report will be submitted when the evaluation is complete.

Manufacturer Narrative

The complaint investigation for false nonreactive architect syphilis tp results included a search for similar complaints, and the review of complaint text, trending data, labeling, in-house testing, and device history records.Return testing was not performed as returns were not available.A review of tracking and trending did not identify any related trends for the product for the complaint.The device history record was reviewed and did not identify any non-conformances or deviations associated with the reagent lot number and complaint issue.In-house testing was performed on a retained reagent kit of the complaint lot in a sensitivity set up.All controls met specifications and no false non-reactive results were obtained, indicating that the sensitivity performance is not negatively impacted.Labeling was reviewed and adequately addresses the issue under review.Based on the investigation, no systemic issue or product deficiency for architect syphilis tp reagent lot 37015be01 was identified.

• Brand Name: ARCHITECT 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: 15703031
• MDR Text Key: 303721567
• Report Number: 3002809144-2022-00381
• 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: 12/14/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/31/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 01/24/2023
• Device Catalogue Number: 08D06-74
• Device Lot Number: 37015BE01
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 11/28/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 02/16/2022
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: ARC I2000SR INST, 03M74-02, (B)(6); ARC I2000SR INST, 03M74-02, (B)(6)