MAUDE Adverse Event Report: ABBOTT IRELAND DIAGNOSTICS DIVISION ARCHITECT HBSAG QUALITATIVE II

Catalog Number 02G22-30

Device Problem False Negative Result (1225)

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

Event Date 04/27/2020

Event Type  malfunction  

Manufacturer Narrative

There was no further patient information provided by the customer.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 2g22 that has a similar product distributed in the us, list number 4p53.

Event Description

The customer observed false nonreactive architect (b)(6) qualitative ii results on one patient.The results were provided: on (b)(6) 2020 sid (b)(6) initial (b)(6) result=0.7497 s/co ( <1.00 s/co= nonreactive) / (previous history=(b)(6) reactive last year) / on (b)(6) 2020 repeated results= 0.7276 s/co ( nonreactive) and 140.4914 s/co (> or =1.00 s/ co=reactive) / confirmatory result c1=0.1067 s/co (na), c2=0.7080 s/co (reactive), n%=114.8148 (confirmed positive).

Manufacturer Narrative

A review of tickets was performed for reagent architect hbsag qualitative ii lot number 04361fn00.The ticket search determined that there is normal complaint activity for the likely cause lot.A review of tracking and trending did not identify any trends for the complaint issue.Return testing was not completed as returns were not available.Historical performance of reagent lot 04361fn00 was evaluated using world wide data from abbottlink.This evaluation indicated that the patient median result for lot 04361fn00 is within the established baseline and comparable with other lot number in the field.Therefore, no unusual reagent lot performance was identified.A review of the manufacturing documentation did not identify any issues associated with the complaint issue.A review of the product labeling concluded that the issue is sufficiently addressed.Based on the investigation no product deficiency was identified for the architect hbsag qualitative ii, lot 04361fn00.

• Brand Name: ARCHITECT HBSAG QUALITATIVE II
• Type of Device: HBSAG
• Manufacturer (Section D): ABBOTT IRELAND DIAGNOSTICS DIVISION; finisklin business park; diagnostics division; sligo NA ; EI NA
• MDR Report Key: 10082553
• MDR Text Key: 229569025
• Report Number: 3008344661-2020-00038
• Device Sequence Number: 1
• Product Code: LOM
• 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: 07/01/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/22/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 05/07/2020
• Device Catalogue Number: 02G22-30
• Device Lot Number: 04361FN00
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 07/01/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: ARCHITECT I2000SR ANALYZER; ARCHITECT I2000SR ANALYZER; LIST 03M74-65, SERIAL (B)(6) ; LIST 03M74-65, SERIAL # (B)(6)