MAUDE Adverse Event Report: ABBOTT IRELAND ARCHITECT HBSAG QUALITATIVE

Catalog Number	04P53-25
Medical Device Problem Code	High Test Results (2457)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	02/02/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Patient identifier = (b)(6).An evaluation is in process.A follow-up report will be submitted when the evaluation is complete.There was no additional patient information provided by the customer.
Event or Problem Description
The customer reported (b)(6) results on one patient.The results provided were: (b)(6) on (b)(6) 2019 repeat (b)(6) testing = confirmed / on (b)(6) 2019 same patient new sample sid (b)(6) / same patient new sample on (b)(6) 2019 (b)(6).There was no reported impact to patient management.
Additional Manufacturer Narrative
A search of complaint tickets or file kit testing could not be completed as the lots are unknown.A review of complaints for the assays determined that there are no trends for the products for the complaint issue.Return testing was not completed as returns were not available.Historical performance of the architect hbsag qual and hbsag confirmatory assays for negative samples shows that all lots on market have median values that do not exceed 2sd above the established baselines, confirming no systemic issues in the field.A review of the manufacturing documentation did not identify any issues associated with the customer's observation.A review of the product labeling concluded that the issue is sufficiently addressed.It is possible that the initial false reactive/false confirmed result observed for one specific sample draw was due to sample or reagent handling/integrity issues at the time of testing, as testing of new sample draws returned the expected non-reactive hbsag qualitative results.Based on the investigation no product deficiency was identified for either the architect hbsag qualitative or the architect hbsag confirmatory assays.

• Brand Name: ARCHITECT HBSAG QUALITATIVE
• Common Device Name: HBSAG
• Manufacturer (Section D): ABBOTT IRELAND; diagnostics division; finisklin business park; sligo NA ; EI NA
• MDR Report Key: 8704798
• Report Number: 3008344661-2019-00076
• Device Sequence Number: 2387055
• Product Code: KSJ
• UDI-Device Identifier: 00380740007775
• UDI-Public: 00380740007775
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: health professional
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 09/05/2019

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
• Operator of Device: Health Professional
• Device Catalogue Number: 04P53-25
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: Yes
• Initial Date Received by Manufacturer: 05/28/2019
• Supplement Date Received by Manufacturer: 08/30/2019
• Initial Report FDA Received Date: 06/17/2019
• Supplement Report FDA Received Date: 09/05/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: ARCHITECT I2000SR ANALYZER, LIST # 03M74-02,; ARCHITECT I2000SR ANALYZER, LIST # 03M74-02,; SERIAL # (B)(4); SERIAL # (B)(4)