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 Consequences Or Impact To Patient (2199)

Event Date 10/20/2020

Event Type  malfunction  

Manufacturer Narrative

An evaluation is in process.A follow-up report will be submitted when the evaluation is complete.All available patient information was included.Additional patient details are not available.

Event Description

The customer reported that negative architect (b)(6) results were generated for two patients that tested reactive by tppa method.Patient 1: architect (b)(6) nonreactive at 0.04 s/co, roche method nonreactive, tppa reactive.(b)(6) year old male patient in the dermatology clinic.Patient 2: architect (b)(6) nonreactive at 0.90 s/co, architect (b)(6) repeat nonreactive 0.81 s/co, roche method reactive, tppa reactive.No patient information available.No adverse impact to patient management was reported.

Manufacturer Narrative

The complaint investigation for false reactive results tested with the architect syphilis tp assay 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 testing of an inhouse retained kit of the complaint lot number.Trending review determined no adverse trend for the issue for the product.Device history record review did not identify any non-conformances or deviations with the likely cause lot and complaint issue.A reagent kit of the complaint lot was tested in a sensitivity setup.All specifications were met and no false non-reactive results were obtained, indicating that the sensitivity performance is not negatively impacted.Based on the investigation, no systemic issue or deficiency with the architect syphilis tp reagent lot 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
• MDR Report Key: 10748969
• MDR Text Key: 241306142
• Report Number: 3002809144-2020-01061
• Device Sequence Number: 1
• Product Code: LIP
• Combination Product (y/n): N
• PMA/PMN Number: K153730
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional
• Type of Report: Initial,Followup
• Report Date: 12/28/2020

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: 01/02/2021
• Device Catalogue Number: 08D06-77
• Device Lot Number: 12693BE01
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 10/20/2020
• Initial Date FDA Received: 10/28/2020
• Supplement Dates Manufacturer Received: 12/22/2020
• Supplement Dates FDA Received: 12/28/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: ARC I2000SR INST, 03M74-02, (B)(4); ARC I2000SR INST, 03M74-02, (B)(4)
• Patient Age: 21 YR