MAUDE Adverse Event Report: ABBOTT GMBH ARCHITECT SYPHILIS TP

Model Number N/A

Device Problem False Positive Result (1227)

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

Event Date 06/15/2020

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 false reactive architect (b)(6) tp assay results for three patients.The customer provided: pt#1 initial = 5.74 s/co; pt#2 initial = 1.2 s/co; pt#3 initial = 5.25 s/co (ref.Range: 1.0 s/co = nonreactive; = > 1.0 s/co = reactive).The customer stated tppa (a (b)(6) antibody assay) test were nonreactive.There was no impact to patient management reported.

Manufacturer Narrative

The evaluation of the customers issue included a review of data and information provided by the customer, a search for similar complaints, ticket trending review, labeling review, device history record review and inhouse testing of retained kits with the complaint lot number as no customer returns were available for investigation.Inhouse testing determined that the specificity performance is not negatively impacted.Complaint searches determined that there is normal complaint activity for the likely cause for lot.Labeling review concludes that the issue is adequately addressed.Trending review determined no trend for this issue for the product.Device history record review did not identify any non-conformances or deviations for lot 08519be01 and customers issue.Based on all available information no product deficiency was identified.

• 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: 10214574
• MDR Text Key: 230615508
• Report Number: 3002809144-2020-00539
• 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
• Report Date: 08/12/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/30/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 08/19/2020
• Device Model Number: N/A
• Device Catalogue Number: 08D06-74
• Device Lot Number: 08519BE01
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 07/22/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: ARCHITECT I2000SR INSTRUMENT; ARCHITECT I2000SR INSTRUMENT,; LN 03M74-02, SN I(B)(6); LN 03M74-02, SN(B)(6)