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

Catalog Number 06C30-27

Device Problem False Negative Result (1225)

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

Event Date 10/23/2017

Event Type  malfunction  

Manufacturer Narrative

An evaluation is in process.A follow-up report will be submitted when the evaluation is complete.This report is being filed on an international product, list number 6c30 that has a similar product distributed in the us, list number 6l21.

Event Description

The customer obtained (b)(6) architect havab-igm results from one patient while testing it multiple times.(b)(6) generated two (b)(6) results (b)(6) and generated multiple (b)(6) results ranging from (b)(6).The sample also generated (b)(6) results on a second reagent lot.No specific patient information was provided.No adverse impact to patient management was reported.

Manufacturer Narrative

Further investigation of the customer issue included a review of the complaint text, a search for similar complaints, in-house testing and a review of labeling.Ticket searches determined that there is normal complaint activity for the likely cause lot number.Tracking and trending report review for the architect havab-igm assay determined that there are no related non-statistical or adverse trends.The clinical sensitivity of reagent lot 77622li00 was evaluated by testing one commercially available seroconversion panel.The seroconversion panel results were compared with historical architect havab igm data provided by the panel manufacturer.The complaint lot detected the same first bleed as (b)(6) with comparable (b)(6) values.Manufacturing documentation for the likely cause lot did not identify any issues associated with the complaint issue.Additionally, labeling was reviewed and sufficiently addresses the customer's issue.Based on the available information, no systemic issue or deficiency of the architect havab-igm assay was identified.

• Brand Name: ARCHITECT HAVAB IGM
• Type of Device: IGM ANTI-HAV
• Manufacturer (Section D): ABBOTT GERMANY; max-planck-ring 2; wiesbaden 65205 ; GM 65205
• MDR Report Key: 7014786
• MDR Text Key: 92659251
• Report Number: 3002809144-2017-00147
• Device Sequence Number: 1
• Product Code: LOL
• 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: 01/30/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 01/08/2018
• Device Catalogue Number: 06C30-27
• Device Lot Number: 77622LI00
• Was Device Available for Evaluation?: Yes
• Initial Date Manufacturer Received: 10/23/2017
• Initial Date FDA Received: 11/09/2017
• Supplement Dates Manufacturer Received: 01/30/2018
• Supplement Dates FDA Received: 01/30/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: ARCHITECT I2000SR ANALYZER; ARCHITECT I2000SR ANALYZER; LIST 03M74-01, SERIAL (B)(4); LIST 03M74-01, SERIAL (B)(4)