MAUDE Adverse Event Report: ABBOTT IRELAND ARCHITECT HBSAG QUALITATIVE

Catalog Number	04P53-25
Medical Device Problem Code	False Positive Result (1227)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	08/11/2017
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.
Event or Problem Description
The customer reported a false repeat reactive (2.61, 2.60, 2.60 s/co) architect hbsag result for a (b)(6) male dialysis patient.The customer further indicated the architect hbsag confirmatory result was 98%.The customer further indicated a month later the patient generated non reactive results.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 field data, 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 75060fn00.Using world wide field data the historical performance of reagent lot 75060fn00 was evaluated and compared to the performance of all architect hbsag reagent lots in the field for the last 12 months.The median value for the negative population of the complaint lot was similar to the median values for other architect hbsag reagent lots.This evaluation indicates lot 75060fn00 is performing similar to other 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: 6901145
• Report Number: 3008344661-2017-00087
• Device Sequence Number: 16474888
• Product Code: KSJ
• UDI-Device Identifier: 00380740007775
• UDI-Public: 00380740007775
• Combination Product (Y/N): N
• Initial Reporter State: FL
• 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): 10/23/2017

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: 12/10/2017
• Device Catalogue Number: 04P53-25
• Device Lot Number: 75060FN00
• Was Device Available for Evaluation?: Yes
• Initial Date Received by Manufacturer: 09/17/2017
• Supplement Date Received by Manufacturer: 10/20/2017
• Initial Report FDA Received Date: 09/28/2017
• Supplement Report FDA Received Date: 10/23/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 62 YR