MAUDE Adverse Event Report: ABBOTT GMBH ARCHITECT SYPHILIS TP

Catalog Number 08D06-32

Device Problem False Negative Result (1225)

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

Event Date 01/23/2020

Event Type  malfunction  

Manufacturer Narrative

Complete information for section a.Patient information 1.Patient identifier = sid010123040009.An evaluation is in process.A follow-up report will be submitted when the evaluation is complete.There was no additional patient information provided due to privacy issues.This report is being filed on an international product, list number 8d06-32 that has a similar product distributed in the us, list number 8d06-31.

Event Description

The customer reported false nonreactive architect syphilis results on one patient.The results provided were: on 23jan2020 sid010123040009 initial = 0.04s/co (<1.00s/co = nonreactive) / the next day new sample same patient on roche cobas = positive.A new sample at the beginning of march = nonreactive.There was no reported impact to patient management.

Manufacturer Narrative

A review of tickets determined that there is normal complaint activity for lot 11036be00, 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 11036be00 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 11036be00.

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: 9912213
• MDR Text Key: 187552575
• Report Number: 3002809144-2020-00282
• 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: 06/16/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/01/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 11/13/2020
• Device Catalogue Number: 08D06-32
• Device Lot Number: 11036BE00
• 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 I1000SR ANALYZER, LN 01L86-01.; ARCHITECT I1000SR ANALYZER, LN 01L86-01.; ARCHITECT I1000SR ANALYZER, LN 01L86-01.; SERIAL # (B)(6). ; SERIAL # (B)(6). ; SERIAL # (B)(6).