MAUDE Adverse Event Report: ABBOTT IRELAND ARCHITECT HBSAG QUALITATIVE

Catalog Number	04P53-35
Medical Device Problem Code	False Positive Result (1227)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	02/14/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
An evaluation is in process.A follow-up report will be submitted when the evaluation is complete.Incomplete sample id entered in section: patient identifier due to field limitations, the correct identifier is (b)(6).Patient information, no further patient information was provided by the customer.
Event or Problem Description
The customer reported a (b)(6) results, while using the architect (b)(6) qualitative and architect (b)(6) qualitative confirmatory assays.Sample id (b)(6) generated a repeat reactive (b)(6) result of 1.61, 13.08 and 5.04 s/co) and confirmatory testing confirmed at 93%.The original and a second sample from the patient were retested in duplicate generating negative results ranging from 0.16 to 0.33 s/co.No adverse impact to patient management was reported.
Additional Manufacturer Narrative
Further investigation of the customer issue included a review of the complaint text, a search for similar complaints, review of instrument logs, review of field performance, review of manufacturing documents and a review of labeling.Review of complaint activity did not identify any adverse or non-statistical trends for the architect hbsag qualitative assay.Normal complaint activity was identified for reagent lot 79225fn00.The customer's instrument logs were reviewed.All of the (b)(6) qualitative results obtained on (b)(6) 2018 for the patient showed no atypical signal profiles.Retest of the original sample and a second sample from the same patient one day later generated consistent (b)(6) qualitative results using the same reagent kit of lot 79225fn00 on the same analyzer as the initial testing.Using world wide field data the specificity of reagent lot 79225fn00 was evaluated and compared to the performance of other on-market reagent lots in the field.This evaluation indicated that the patient median result for lot 79225fn00 was similar to other architect (b)(6) qualitative reagent lots in the field.Manufacturing documentation for the likely cause lot was reviewed and did not identify any issues associated with false positive results.Labeling was reviewed and sufficiently addresses the customer's issue.No systemic issue or deficiency of the architect hbsag qualitative assay was identified.

• 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: 7325338
• Report Number: 3008344661-2018-00015
• Device Sequence Number: 16170454
• Product Code: KSJ
• UDI-Device Identifier: 00380740007782
• UDI-Public: 00380740007782
• Combination Product (Y/N): N
• Initial Reporter State: GA
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: health professional
• Initial Reporter Occupation: Health Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 04/11/2018

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
• Operator of Device: Health Professional
• Device Expiration Date: 05/08/2018
• Device Catalogue Number: 04P53-35
• Device Lot Number: 79225FN00
• Was Device Available for Evaluation?: Yes
• Initial Date Received by Manufacturer: 02/19/2018
• Supplement Date Received by Manufacturer: 04/04/2018
• Initial Report FDA Received Date: 03/08/2018
• Supplement Report FDA Received Date: 04/11/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1