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

Catalog Number 08D06-77

Device Problem False Positive Result (1227)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 12/10/2020

Event Type  malfunction  

Manufacturer Narrative

An evaluation is in process.A follow-up report will be submitted when the evaluation is complete.No further patient information is available.This report is being filed on an international product, list number 08d06-77 that has a similar product distributed in the us, list number 8d06-31.

Event Description

The customer generated falsely positive architect (b)(6) tp results for one patient.The following data was provided: sid (b)(6) initial result 4.15 s/co, repeat 4.24 and 4.40 s/co.The patient is a (b)(6) old female with liver dysfunction and is rpr negative.The parents have indicated no history of syphilis, and the mother tested negative for syphilis antibodies.No impact to patient management was reported.

Event Description

The customer generated falsely positive architect syphilis tp results for one patient.The following data was provided: sid (b)(6) initial result 4.15 s/co, repeat 4.24 and 4.40 s/co.The patient is a 9 month old female with liver dysfunction and is rpr negative.The parents have indicated no history of syphilis, and the mother tested negative for syphilis antibodies.No impact to patient management was reported.

Manufacturer Narrative

A review of tickets was performed for reagent lot number 12693be01.The ticket search determined that there is normal complaint activity for the likely cause lot.A review of tracking and trending did not identify any trends for the complaint issue.Return testing was not completed as returns were not available.A retained reagent kit of lot number 12693be01was tested in a specificity setup.Results of this setup did not implicate that the performance regarding specificity of the lot is negatively impacted as no false reactive results were obtained.A review of the manufacturing documentation did not identify any issues associated with the complaint issue.A review of labeling concluded that the issue is sufficiently addressed.Based on the investigation no systemic issue or deficiency of the architect syphilis tp assay for lot 12693be01was 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: 11040709
• MDR Text Key: 241307320
• Report Number: 3002809144-2020-01197
• 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: 01/13/2021

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: 12/10/2020
• Initial Date FDA Received: 12/18/2020
• Supplement Dates Manufacturer Received: 12/22/2020
• Supplement Dates FDA Received: 01/13/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: ARC I2000SR INST, 03M74-02, ISR63176; ARC I2000SR INST, 03M74-02, ISR63176
• Patient Age: 9 MO