MAUDE Adverse Event Report: ABBOTT GERMANY ARCHITECT SYPHILIS TP

Catalog Number 08D06-39

Device Problem Low Test Results (2458)

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

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, list number 8d06-39 that has a similar product distributed in the us, list number 8d06-41.There is no further patient information provided by the customer.

Event Description

The customer reported false nonreactive architect syphilis results on one patient.The results provided were: architect = nonreactive / weigao method = positive.The customer believes the architect results are correct based on the patient's clinical data.There was no reported impact to patient management.

Manufacturer Narrative

A review of tickets determined that there is no increase in complaints for lot 91382li00, 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 91382li00 and a sensitivity panel.Results of this setup did not implicate that the performance of the used lots 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 91382li00.

• 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: 8446723
• MDR Text Key: 139702696
• Report Number: 3002809144-2019-00118
• 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: 04/22/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/24/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 06/21/2019
• Device Catalogue Number: 08D06-39
• Device Lot Number: 91382LI00
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 04/03/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: ARCHITECT I2000SR ANALYZER, LIST # 03M74-02,; ARCHITECT I2000SR ANALYZER, LIST # 03M74-02,; SERIAL # (B)(4); SERIAL # (B)(4)