MAUDE Adverse Event Report: ABBOTT GERMANY ARCHITECT SYPHILIS TP

Catalog Number 08D06-77

Device Problem Low Test Results (2458)

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

Event Type  malfunction  

Manufacturer Narrative

All available patient information was included.Additional patient details are not available.An evaluation is in process.A final report will be submitted when the evaluation is complete.This report is being filed on an international product, list number 08d06-39 that has a similar product distributed in the us, list number 08d06-41.

Event Description

The customer reported (b)(6) architect syphilis results on one female patient.The results provided were: architect = (b)(6) / rpr 1:4 = (b)(6) / tppa = (b)(6); all three methods were retested with similar results.The patient is historically (b)(6) for syphilis at other facilities, unknown methods.There was no reported impact to patient management.

Manufacturer Narrative

A review of tickets determined that there is normal complaint activity for lot 04643be01 and no trends were identified.Return testing was not completed as returns were not available.Sensitivity testing was performed with a retained kit of lot 04643be00 (contains the same material as lot 04643be01) and a sensitivity panel.Results of this setup did not implicate that the performance of the lot is negatively impacted.No false non-reactive results were obtained.A review of the manufacturing documentation did not identify any issues associated with the customer's observation.A review of the product labeling concluded that the issue is sufficiently addressed.Based on the investigation no product deficiency was identified for the architect syphilis tp reagent, lot 04643be01.Correction to suspect medical device, 4.Catalog# from 08d06-36 to 08d06-77, lot # from 04643be00 to 04643be01, and udi from (b)(4) to blank.

• Brand Name: ARCHITECT SYPHILIS TP
• Type of Device: SYPHILIS
• Manufacturer (Section D): ABBOTT GERMANY; max-planck-ring 2; wiesbaden 65205 ; GM 65205
• MDR Report Key: 9070989
• MDR Text Key: 159028024
• Report Number: 3002809144-2019-00558
• Device Sequence Number: 1
• Product Code: MTN
• Combination Product (y/n): N
• 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: 11/19/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/16/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 04/25/2020
• Device Catalogue Number: 08D06-77
• Device Lot Number: 04643BE01
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 11/19/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: ARCHITECT I2000SR ANALYZER, LN 03M74-02; ARCHITECT I2000SR ANALYZER, LN 03M74-02; SERIAL # (B)(4); SERIAL # (B)(4)