MAUDE Adverse Event Report: ABBOTT IRELAND ARCHITECT HBSAG QUALITATIVE CONFIRMATORY; HBSAG CONFIRMATORY

Catalog Number	04P54-25
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: 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 hbsag qualitative and architect hbsag qualitative confirmatory assays.Sample id (b)(6) generated a repeat (b)(6) result of (b)(6) and confirmatory testing confirmed at 93%.The original and a second sample from the patient were retested in duplicate generating negative results ranging from (b)(6).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 customer instrument logs, 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 confirmatory assay.Normal complaint activity was identified for reagent lot 81136fn00.The customer's instrument logs were reviewed.All of the reactive hbsag qualitative and confirmatory results obtained on (b)(6) 2018 for the patient showed no atypical signal profiles.Investigation testing was performed for the architect hbsag qualitative confirmatory reagent lot 81136fn00.Testing of negative panels which mimic patient samples was performed using a retained kit of lot 81136fn00.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 false positive results.Labeling was reviewed and sufficiently addresses the customer's issue.No systemic issue or deficiency of the architect hbsag qualitative confirmatory assay was identified.

• Brand Name: ARCHITECT HBSAG QUALITATIVE CONFIRMATORY
• Common Device Name: HBSAG CONFIRMATORY
• Manufacturer (Section D): ABBOTT IRELAND; diagnostics division; finisklin business park; sligo NA ; EI NA
• MDR Report Key: 7325334
• Report Number: 3008344661-2018-00014
• Device Sequence Number: 110253
• Product Code: LOM
• UDI-Device Identifier: 00380740007799
• UDI-Public: 00380740007799
• Combination Product (Y/N): N
• Initial Reporter State: GA
• Initial Reporter Country: US
• PMA/510(K) Number: P110029
• 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: 06/06/2018
• Device Catalogue Number: 04P54-25
• Device Lot Number: 81136FN00
• 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
• Concomitant Medical Products and Therapy/Usage Dates: ARCHITECT I2000SR ANALYZER; ARCHITECT I2000SR ANALYZER; LIST 03M74-02, SERIAL (B)(4); LIST 03M74-02, SERIAL (B)(4)