MAUDE Adverse Event Report: ABBOTT GMBH ARCHITECT HAVAB-G; IGG ANTI-HAV

Model Number N/A

Device Problem False Positive Result (1227)

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

Event Date 05/29/2020

Event Type  malfunction  

Manufacturer Narrative

An evaluation is in process.A follow-up report will be submitted when the evaluation is complete.

Event Description

The customer observed (b)(6) architect (b)(6) results on 2 patients.Patient #1 generated a result of (b)(6), repeat (b)(6).Patient #2 generated a result of (b)(6), repeat (b)(6).The reference range for (b)(6) is (b)(6) and (b)(6).There was no impact to patient management reported.

Manufacturer Narrative

The complaint investigation for false reactive results for two samples tested with the architect havab-g assay 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 field data review.No customer returns were available.A ticket search by lot indicated that lot 14054be00 performed as expected.Trending review determined no related trends for the issue for the product.Device history record review did not identify any non-conformances or deviations associated with the likely cause lot and complaint issue.The overall performance of architect havab-g reagents in the field was reviewed using worldwide data and suggested that the performance of the complaint lot is acceptable.Labeling review concludes that the issue was adequately addressed.Based on the investigation, there is no systemic issue and/or product deficiency for the architect havab-g reagent lot identified in this complaint.

• Brand Name: ARCHITECT HAVAB-G
• Type of Device: IGG ANTI-HAV
• Manufacturer (Section D): ABBOTT GMBH; max-planck-ring 2; wiesbaden 65205 ; GM 65205
• MDR Report Key: 10170219
• MDR Text Key: 197089662
• Report Number: 3002809144-2020-00483
• Device Sequence Number: 1
• Product Code: LOL
• UDI-Device Identifier: 00380740011185
• UDI-Public: 00380740011185
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional
• Type of Report: Initial,Followup
• Report Date: 09/07/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/18/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 02/06/2021
• Device Model Number: N/A
• Device Catalogue Number: 06L27-25
• Device Lot Number: 14054BE00
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 08/28/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: ARCHITECT I1000SR ANALYZER,; ARCHITECT I1000SR ANALYZER, LIST 01L86-01; LIST 01L86-01, SERIAL (B)(6); SERIAL (B)(6)