MAUDE Adverse Event Report: ABBOTT IRELAND ARCHITECT HBSAG QUALITATIVE

Catalog Number	04P53-35
Medical Device Problem Code	False Negative Result (1225)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	12/11/2017
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 (b)(6) architect (b)(6) result from a female dialysis patient.Sample id (b)(6) generated a (b)(6) result of (b)(6).A new sample (sid (b)(6) ) collected two days later generated repeat (b)(6) results ((b)(6)) and confirmed (b)(6) (93% neutralization).Both samples were retested sid (b)(6) generated a (b)(6) ) result and sid (b)(6) generated (b)(6).No further information was provided and no adverse impact to patient management was reported.
Additional Manufacturer Narrative
Further investigation of the issue included a review of the complaint text, a search for similar complaints, in-house testing, 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 79116fn00.Testing of panels which mimic patient samples was performed using retained kits of lot 79116fn00.All specifications were met indicating that the lot is performing acceptably.Manufacturing documentation for the likely cause lot was reviewed and did not identify any issues associated with the complaint issue.Labeling was reviewed and sufficiently addresses the customer's issue.No systemic issue or deficiency of the architect hbsag qualitative confirmatory assay was identified.Update march 19, 2018: suspect medical device: the lot number was incorrectly documented in the serial number field in the initial medical device report.The lot number has been entered in the correct lot number field.

• 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: 7148684
• Report Number: 3008344661-2017-00109
• Device Sequence Number: 11040220
• 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): 03/19/2018

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: 04/09/2018
• Device Catalogue Number: 04P53-35
• Device Lot Number: 79116FN00
• Was Device Available for Evaluation?: Yes
• Initial Date Received by Manufacturer: 12/12/2017
• Supplement Date Received by Manufacturer: 03/07/2018
• Initial Report FDA Received Date: 12/27/2017
• Supplement Report FDA Received Date: 03/19/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1