MAUDE Adverse Event Report: ABBOTT GERMANY ARCHITECT SYPHILIS TP

Catalog Number 08D06-77

Device Problem Low Test Results (2458)

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

Event Date 10/14/2019

Event Type  malfunction  

Manufacturer Narrative

An evaluation is in process.A follow-up report will be submitted when the evaluation is complete.There is no further patient information provided due to privacy issues.This report is being filed on an international product, list number 8d06-77 that has a similar product distributed in the us, list number 8d06-31/-41.

Event Description

The customer reported false nonreactive architect (b)(6) results from two (b)(6) old twins.The results provided were pt#1 = 0.69s/co(<1.00s/co = nonreactive) / re-spun and retested = 0.72s/co / mindray result = 1.7s/co = reactive; pt#2 = 0.71s/co / repeated = 0.74s/co/ mindray = 1.9s/co; colloidal gold test x2 = positive; and tppa tests were positive for both samples.The mother of the twins is reactive for (b)(6).There was no reported impact to patient management.

Manufacturer Narrative

Lot # from incorrect 02284be00 to correct 02284be01.A review of tickets determined that there is a normal complaint activity for lot 02284be01.The tracking and trending report review determined that there are no trends identified related to this issue.Return testing was not completed as returns were not available.Sensitivity testing was performed with a retained kit of lot 02284be00 (same bulk as 02284be01) 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 02284be01.

• 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: 9272572
• MDR Text Key: 219780164
• Report Number: 3002809144-2019-00790
• 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: 12/18/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/04/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 02/11/2020
• Device Catalogue Number: 08D06-77
• Device Lot Number: 02284BE01
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 12/18/2019
• 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 # (B)(4); SERIAL # (B)(4)
• Patient Age: 3 MO