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

Catalog Number 08D06-77

Device Problem False Negative Result (1225)

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

Event Date 11/30/2022

Event Type  malfunction  

Event Description

The customer observed a false non-reactive architect syphilis tp result for a 74-year-old female patient with facial neuritis.The following data was provided (<1.00 s/co is nonreactive, >/=1.00 s/co is reactive): snibe syphilis result = 10.23 s/co, repeat result on roche = 2.4 s/co abbott architect sample id (b)(6) initial result = 0.84 s/co, repeat result with sample id (b)(6) = 0.82 s/co rapid plasma reagin (rpr) = negative no impact to patient management was reported.

Manufacturer Narrative

An evaluation is in process.A final report will be submitted when the evaluation is complete.All available patient information was included.Additional patient details are not available.  phone complete entry = (b)(6).This report is being filed on an international product, list number 8d06-77 has a similar product distributed in the us, list number 8d06-31/-41.

Manufacturer Narrative

Corrected information in section d9 - date returned to mfg.

Manufacturer Narrative

The complaint investigation for false non-reactive architect 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, return sample analysis, and in house testing.Trending review did not identify any trends for the issue for the product.Device history record review did not identify any non-conformances or deviations with lot number 37093be01 and the complaint issue.Labeling was reviewed and sufficiently addresses the customer's issue.The return sample analysis for sample id 10 was tested with the following results: architect syphilis tp: 0.87 s/co (non-reactive), recomline treponema igm: negative, recomline treponema igg: negative.In-house testing of a retained reagent kit of the complaint lot was performed.All controls met specifications and no false non-reactive results were obtained, indicating that the lot generates the expected results.Based on the investigation, since no discrepant results were generated during return sample testing with other methods, architect syphilis tp reagent, lot number 37093be01 is performing as intended, no systemic issue or deficiency 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: 15959995
• MDR Text Key: 308383833
• Report Number: 3002809144-2022-00433
• 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,Followup
• Report Date: 02/13/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/12/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 01/28/2023
• Device Catalogue Number: 08D06-77
• Device Lot Number: 37093BE01
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 02/08/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 03/11/2022
• 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); ARC I2000SR INST, 03M74-02, (B)(6)
• Patient Age: 74 YR
• Patient Sex: Female