MAUDE Adverse Event Report: ABBOTT GMBH ARCHITECT ANTI-HCV

Catalog Number 06C37-27

Device Problem False Negative Result (1225)

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

Event Date 08/17/2020

Event Type  malfunction  

Manufacturer Narrative

Patient identifier: (b)(6).All available patient information has been included.No additional patient details are available.This report is being filed on an international product, list number 6c37 that has a similar product distributed in the us, list number 1l79.An evaluation is in process.A follow-up report will be submitted when the evaluation is complete.

Event Description

The customer reported false nonreactive architect (b)(6) results on one patient.The following data was provided: sid (b)(6) initial = 0.35 s/co (nonreactive), repeated 1.67 and 1.85 s/co (reactive) (reference range greater than or equal to 1.00 = reactive).The patient historically tested positive (1.72 and 1.1 s/co).No impact to patient management was reported.

Manufacturer Narrative

The complaint investigation included a review of data and information provided by the customer, search for similar complaints, ticket trending review, labeling review, device history record review and in-house testing of the complaint lot number.Return testing was not completed as returns were not available.Trending review did not identify any trends for the issue for the product.Device history record review did not identify any issues with the likely cause lot and complaint issue.A retained file reagent kit of the complaint lot was tested in a sensitivity setup and inhouse testing determined that the sensitivity performance of the lot was acceptable.A review of the product labeling concluded that the issue is sufficiently addressed.Based on the investigation, no systemic issue or deficiency of the architect anti-hcv reagent lot number 14465be00 was identified.

• Brand Name: ARCHITECT ANTI-HCV
• Type of Device: ANTI-HCV
• Manufacturer (Section D): ABBOTT GMBH; max-planck-ring 2; wiesbaden 65205 ; GM 65205
• MDR Report Key: 10489226
• MDR Text Key: 241306061
• Report Number: 3002809144-2020-00884
• Device Sequence Number: 1
• Product Code: MZO
• 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: 09/11/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/03/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 12/03/2020
• Device Catalogue Number: 06C37-27
• Device Lot Number: 14465BE00
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 09/10/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: ARCHITECT I1000SR ANALYZER, LIST 01L86-01,; ARCHITECT I1000SR ANALYZER, LIST 01L86-01,; SERIAL (B)(6); SERIAL (B)(6)