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)
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.All available patient information was included.Additional patient details are not available.
Event or Problem Description
The customer reported a (b)(6) qualitative results when processing on the architect i2000sr.Additional rna/dna testing was (b)(6).The initial result was (b)(6) and retest results were (b)(6).A new sample was drawn and yielded results of (b)(6).Another retest of the original sample generated results of (b)(6).Confirmatory and neutralization testing yielded results of (b)(6), respectively.No impact to patient management was reported.
Additional Manufacturer Narrative
An investigation was performed for the customer issue and included a review of complaint text, a search for similar complaints, complaint trending report review, testing of retained kit of lot 91396fn00, and a review of product labeling.Ticket searches determined normal complaint activity for all three lots with this being the only complaint received to date for lots 92145fn00 and 94039fn00.Trending report review determined there are no non-statistical or adverse trends.Lot 91396fn00 was tested using a retained kit and all specifications were met, indicating the lot is preforming acceptably.Data was reviewed for lots 92145fn00 and 94039fn00, and no systemic issue was identified.Labeling was reviewed and found to be adequate.Based on all available information and abbott diagnostics' complaint investigation a product deficiency was not 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: 8315587
• Report Number: 3008344661-2019-00010
• Device Sequence Number: 10779686
• Product Code: KSJ
• UDI-Device Identifier: 00380740007775
• UDI-Public: 00380740007775
• Combination Product (Y/N): N
• Initial Reporter State: IL
• 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): 05/01/2019

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 Expiration Date: 06/01/2019
• Device Catalogue Number: 04P53-25
• Device Lot Number: 92145FN00
• Was Device Available for Evaluation?: Yes
• Initial Date Received by Manufacturer: 01/11/2019
• Supplement Date Received by Manufacturer: 05/01/2019
• Initial Report FDA Received Date: 02/07/2019
• Supplement Report FDA Received Date: 05/01/2019
• 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, LN 03M74-02; ARCHITECT I2000SR ANALYZER, LN 03M74-02; SERIAL (B)(4); SERIAL (B)(4)