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 08d06-39, that has a similar us product distributed in the us, list 8d06-31.There is no additional patient information provided due to privacy issues.

Event Description

The customer reported (b)(6) architect syphilis results on one patient.The results provided were: sid (b)(6): initial result = (b)(6); repeat = (b)(6); rpr= (b)(6); tppa and elisa = (b)(6).There was no reported impact to patient management.

Manufacturer Narrative

A review of tickets determined that there is slightly elevated complaint activity for lot 91382li00, but no trends were identified for the complaint issue.The returned sample was tested with lot 89366li00, as the complaint lot 91382li00 was not available for testing, and nonreactive results of 0.06 s/co and 0.1 s/co were obtained.Although there is no reference test method for the syphilis assay, the sample was also tested with mikrogen recomline treponema igm / igg methods and all generated negative results.Sensitivity testing was performed with a retained kit of lot 91382li00 in a sensitivity setup, including additional replicates of a sensitivity panel.Results of this setup did not implicate that the performance of the lot was negatively impacted, as no false nonreactive 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: 8315694
• MDR Text Key: 135521495
• Report Number: 3002809144-2019-00049
• 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: 05/14/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/07/2019
• 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: 04/23/2019
• 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 # ISR08141; SERIAL # ISR08141