MAUDE Adverse Event Report: ABBOTT GMBH ARCHITECT SYPHILIS TP

Catalog Number 08D06-42

Device Problem False Positive Result (1227)

Patient Problem No Code Available (3191)

Event Date 10/09/2019

Event Type  Injury  

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, architect syphilis list 08d06-42 that has a similar product distributed in the us, list 08d06-31/-41.

Event Description

The customer reported a (b)(6) result on the architect i2000sr analyzer.The following data was provided: sid (b)(6) generated 2.97 s/co and confirmed (b)(6) at the reference lab as past infection.The patient was tested at a second lab and generated a (b)(6) result.Both samples were retested and generated results matching the initial results (sample 1 (b)(6) and sample 2 (b)(6)).A new sample was collected which also generated a (b)(6) result.The pregnant patient was treated unnecessarily with antibiotics.

Manufacturer Narrative

Further investigation of the customer issue included a review of the complaint text, a search for similar complaints, review of instrument logs, a review of labeling, review of field data and specificity testing.A splash could have occurred to report this reactive result.Labeling was reviewed and found to be adequate: the following is listed in the section of the architect system operations manual, section 5, sample management: avoid splashing outside of the sample cups and/or tubes.No adverse trend was identified for the customer's issue.No return patient sample was available.Clinical specificity testing of negative panel replicates was performed using in-house retained kits stored at the recommended storage condition.Specificity testing met all specifications.Based on all available information and abbott diagnostics' complaint investigation no product deficiency was identified.

• Brand Name: ARCHITECT SYPHILIS TP
• Type of Device: SYPHILIS
• Manufacturer (Section D): ABBOTT GMBH; max-planck-ring 2; wiesbaden 65205 ; GM 65205
• MDR Report Key: 9378082
• MDR Text Key: 176774075
• Report Number: 3002809144-2019-00977
• 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: 01/06/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/26/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 04/25/2020
• Device Catalogue Number: 08D06-42
• Device Lot Number: 04651BE00
• Was Device Available for Evaluation?: Yes
• Date Manufacturer Received: 01/06/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: ARCHITECT I2000SR ANALYZER; ARCHITECT I2000SR ANALYZER; LN 03M74-01 SN (B)(4); LN 03M74-01 SN (B)(4)
• Patient Outcome(s): Other