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 Known Impact Or Consequence To Patient (2692)

Event Date 01/11/2021

Event Type  malfunction  

Manufacturer Narrative

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, architect )b)(6) tp, list 8d06-74, that has a similar product distributed in the us, list number 8d06-31/-41.Complete entry = (b)(6).No further information was provided.

Event Description

The customer obtained a false (b)(6) tp result for a (b)(6) female with a history of (b)(6) infection.Sample id (b)(6) generated a (b)(6) s/co on the architect and negative on rpr.The sample generated positive results on roche 4.54 s/co, autobio 10.16 s/co, colloidal gold rapid test strip and tppa.While troubleshooting the issue the customer also sent the sample to another hospital which tested the sample on an abbott platform and generated a non-reactive results of 0.98 s/co.No impact to patient management was reported.

Manufacturer Narrative

H6 health effect impact code: f26.H6 component code: g01003.D8 was this device serviced by a third party? no.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 review and testing of a retained kit of the complaint lot number.Return testing was not completed as returns were not available.Review of complaint activity and trending reports did not identify any issues or trends related to the complaint issue.Device history record review for the lot did not identify any non-conformances or deviations.A retained 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 acceptable.Based on our investigation, no systemic issue or deficiency of the architect syphilis tp reagent lot was identified.D4 expiration date was changed from 1/21/2021 to 1/20/2021 due to a typo.D10 was changed from yes to no since the device was not available.

Manufacturer Narrative

This follow up is submitted to populate fields d8 and/or h6 with data that had previously been provided in field h10.There is no change to the content of the data.

• 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: 11208566
• MDR Text Key: 243144790
• Report Number: 3002809144-2021-00045
• 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,Followup
• Report Date: 05/18/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/21/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 01/20/2021
• Device Catalogue Number: 08D06-74
• Device Lot Number: 12692BE01
• Was Device Available for Evaluation?: Yes
• Date Manufacturer Received: 05/18/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: ARC I2K PROC MOD, 03M74-01, ISR53944.; ARC I2K PROC MOD, 03M74-01, ISR53944.
• Patient Age: 38 YR