MAUDE Adverse Event Report: ABBOTT GMBH ARCHITECT SYPHILIS TP

Catalog Number 08D06-74

Device Problem False Negative Result (1225)

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

Event Date 03/25/2020

Event Type  malfunction  

Manufacturer Narrative

An evaluation is in process.A follow-up report will be submitted when the evaluation is complete.There was no additional patient information provided by the customer.This report is being filed on an international product, list number 8d06-74 that has a similar product distributed in the us, list number 8d06-31.

Event Description

The customer reported a false nonreactive architect syphilis tp result on one male patient.The following data was provided: on 25mar2020 initial sample = 0.04 s/co (<1.00 s/co = non-reactive), the sample was repeated by domestic luminescence method which = 1.64 s/co and the colloidal gold testing was weakly positive.The riba testing was also negative.There was no impact to patient management reported.

Manufacturer Narrative

A review of tickets determined that there is normal complaint activity for lot 07413be01, and no trends were identified for the complaint issue.Return testing was not completed as returns were not available.Sensitivity testing was performed with a retained kit of lot 07413be00 (lot number 07413be00 and lot number 07413be01 contain the same bulk material) and a 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 07413be01.

Manufacturer Narrative

Corrected information for section d2 product code from incorrect mtn to correct lip.

• 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: 9967474
• MDR Text Key: 187939785
• Report Number: 3002809144-2020-00328
• Device Sequence Number: 1
• Product Code: LIP
• 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,Followup
• Report Date: 06/17/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/16/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 07/12/2020
• Device Catalogue Number: 08D06-74
• Device Lot Number: 07413BE01
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 06/15/2020
• 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,; ARCHITECT I2000SR ANALYZER, LN 03M74-02,; SERIAL # (B)(4); SERIAL # (B)(4); SERIAL # (B)(4); ARCHITECT I2000SR ANALYZER, LN 03M74-02,; SERIAL # (B)(4).