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

Catalog Number 06L27-25

Device Problem Incorrect Or Inadequate Test Results (2456)

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

Event Date 02/02/2018

Event Type  malfunction  

Manufacturer Narrative

An evaluation is in process.A follow-up report will be submitted when the evaluation is complete.Patient information sid (b)(6) , patient is a (b)(6) year old white male diagnosed with (b)(6).Sid (b)(6), patient is a (b)(6) year old white male, diagnosis was not provided.Sid (b)(6), patient is a (b)(6) year old white female diagnosed with cirrhosis of the liver.An evaluation is in process.

Event Description

The customer observed multiple (b)(6) antibody to (b)(6) a virus results while using architect havab-g reagents.The following data was provided.Sid (b)(6).Sid (b)(6).Sid (b)(6).All three patient results were (b)(6) using diasoren eti max method.No impact to patient management was reported.

Manufacturer Narrative

Evaluation of the customer issue included a review of the complaint text, a search for similar complaints, device history review, labeling review, and specificity testing.No adverse trend was identified for the customer issue.Device history review did not identify any issues that may have caused the customer issue.Labeling was reviewed and found to be adequate.No patient sample was available for return, therefore clinical specificity testing of negative control replicates was performed using in-house retained kits stored at the recommended storage condition.Specificity testing met all specifications.Based on all available information and abbott diagnostics evaluation, no systemic issue was identified and no product deficiency was found.

• Brand Name: ARCHITECT HAVAB-G
• Type of Device: IGG ANTI-HAV
• Manufacturer (Section D): ABBOTT GERMANY; max-planck-ring 2; wiesbaden 65205 ; GM 65205
• MDR Report Key: 7342778
• MDR Text Key: 103157604
• Report Number: 3002809144-2018-00027
• 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: 05/29/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/15/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 05/24/2018
• Device Catalogue Number: 06L27-25
• Device Lot Number: 79646LI00
• Date Manufacturer Received: 05/23/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: ARCHITECT I2000SR ANALYZER; ARCHITECT I2000SR ANALYZER; LIST NUMBER 03M74-02; LIST NUMBER 03M74-02; SERIAL NUMBER IS (B)(4).; SERIAL NUMBER IS (B)(4).