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

Catalog Number 06C29-27

Device Problem False Positive Result (1227)

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

Event Date 10/23/2019

Event Type  malfunction  

Manufacturer Narrative

This report is being filed on an international product, list number 6c29 that has a similar product distributed in the us, list number 6l27. Patient information: no specific patient information is available. An evaluation is in process. A final report will be submitted when the evaluation is complete.

Event Description

The customer reported false reactive architect havab igg results for one patient. The patient was previously negative, has not been vaccinated and has no symptoms for hepatitis a. Additionally, the sample was negative for havab igm. No impact to patient management was reported.

• Brand Name: ARCHITECT HAVAB-IGG
• Type of Device: IGG ANTI-HAV
• Manufacturer (Section D): ABBOTT GMBH; max-planck-ring 2; wiesbaden 65205 ; GM 65205
• Manufacturer (Section G): ABBOTT GMBH; max-planck-ring 2; wiesbaden 65205 ; GM 65205
• Manufacturer Contact: christian lee ; 100 abbott park road; dept 09b9, bldg cp01-3; abbott park, IL 60064-3537 ; 224668-294
• MDR Report Key: 9317950
• MDR Text Key: 219783173
• Report Number: 3002809144-2019-00869
• Device Sequence Number: 1
• Product Code: LOL
• Combination Product (y/n): N
• Reporter Country Code: IT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 01/09/2020

1 Device was Involved in the Event

0 Patients were Involved in the Event:

• Date FDA Received: 11/13/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes

Device Operator

• Device Expiration Date: 05/29/2020
• Device Catalogue Number: 06C29-27
• Device Lot Number: 06164BE00
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes

Was the Report Sent to FDA?

• Event Location: No Information
• Date Manufacturer Received: 01/09/2020
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 07/04/2019
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unkown