MAUDE Adverse Event Report: ABBOTT IRELAND DIAGNOSTICS DIVISION ARCHITECT HBSAG

Catalog Number 06C36-44

Device Problem False Positive Result (1227)

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

Event Date 04/21/2020

Event Type  malfunction  

Manufacturer Narrative

Complete information for patient information, patient identifier = sid= (b)(6) and sid (b)(6).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 6c36 that has a similar product distributed in the us, list number 4p53.

Event Description

The customer observed (b)(6) architect hbsag results on one (b)(6) year old male patient diagnosed with chronic kidney disease.The results were provided: on (b)(6) 2020 sid (b)(6) initial hbsag result=(b)(6), anti-hbs=(b)(6)), hbeag= (b)(6), anti-hbe= (b)(6), anti-hbc= (b)(6); redraw same patient on (b)(6) 2020 sid (b)(6) anti-hbsag= (b)(6), anti-hbs result= (b)(6).On (b)(6) 2020 the customer retested sid (b)(6) anti-hbsag result= (b)(6), anti- hbs= (b)(6), hbeag result= (b)(6), anti-hbe result= (b)(6), anti-hbc result= (b)(6) / sid (b)(6) anti-hbsag result= (b)(6), anti-hbs result= (b)(6), hbeag= (b)(6), ani-hbe result=(b)(6), anti-hbc result= (b)(6).The neutralization testing performed later on and results were: sid (b)(6) hbsag c1= (b)(6), hbsag c2= (b)(6), %neuralization rate result=(b)(6) confirmed hbsag= (b)(6), sid (b)(6) hbsag c1=(b)(6), hbsag c2=(b)(6), %neutralization rate result=not applicable, confirmed hbsag=(b)(6).There was no reported impact to patient management.

Manufacturer Narrative

Correction to d2 product code from incorrect ksj to the correct lom.A search of complaints for lot 06418fn00 identified no similar complaints and no trends for the customer's issue.The complaint investigation for potential false negative hbsag results included a search for similar complaints, and review of complaint text, instrument result logs, trending data, labeling, and device history records.In house sensitivity testing of panels which mimic patient samples was completed using a retained kit of lot 06418fn00.All specifications were met indicating that the lot is performing acceptably.Return testing was not completed as returns were not available.Trending review determined no trends for the issue for the product.The patient median result for likely cause lot number of reagent within the established baseline, indicating the lot is performing acceptably.Manufacturing documentation for the likely cause lot was reviewed and did not identify any issues associated with false nonreactive results.Additionally, labeling was reviewed and sufficiently addresses the customer's issue.No systemic issue or deficiency of the architect hbsag assay, lot number 06418fn00 was identified.

Manufacturer Narrative

Updated section b5 with additional information provided by customer.

Event Description

Additional information provided by customer on 29may2020 : the neutralization testing performed later, and results were: sid (b)(6) hbsag c1=0.19, hbsag c2=6.32, %neuralization rate result=100.322 confirmed hbsag= positive, sid (b)(6) hbsag c1=0.25, hbsag c2=0.21, %neutralization rate result=not applicable, confirmed hbsag=negative.The customer agrees that sid (b)(6) is true positive hbsag.Sid (b)(6) hbsag result= nonreactive, which is incorrect.There was no reported impact to patient management.

• Brand Name: ARCHITECT HBSAG
• Type of Device: HBSAG
• Manufacturer (Section D): ABBOTT IRELAND DIAGNOSTICS DIVISION; finisklin business park; diagnostics division; sligo NA ; EI NA
• MDR Report Key: 10024957
• MDR Text Key: 191255069
• Report Number: 3008344661-2020-00034
• 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,Followup
• Report Date: 06/22/2020

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: 08/27/2020
• Device Catalogue Number: 06C36-44
• Device Lot Number: 06418FN00
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 06/22/2020
• Initial Date FDA Received: 05/05/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: ARCHITECT I2000SR ANALYZER; ARCHITECT I2000SR ANALYZER; ARCHITECT I2000SR ANALYZER; LN 03M74-02 (B)(6) ; LN 03M74-02: SERIAL # (B)(6) ; LN 03M74-02: SERIAL # (B)(6)
• Patient Age: 83 YR