MAUDE Adverse Event Report: ABBOTT IRELAND DIAGNOSTICS DIVISION ARCHITECT HBSAG QUALITATIVE

Model Number	4P53-35
Medical Device Problem Code	False Positive Result (1227)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	06/11/2020
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.Patient identifier: (b)(6).
Event or Problem Description
The customer reported false repeat reactive architect (b)(6) results on two patients: results provided: on (b)(6) 2020 sid (b)(6) = 2.09 / 3.55 / 1.89 s/co, confirmed positive by (b)(6) neutralization confirmatory; repeated on (b)(6) 2020 = 0.12 s/co, confirmation = negative.On (b)(6) 2020 sid (b)(6) = 1.19 / 1.32 / 1.6 s/co, confirmed positive by (b)(6) neutralization confirmatory; repeated on (b)(6) 2020 = 0.52 s/co.No impact to patient management was reported.
Additional Manufacturer Narrative
After further evaluation, the suspect medical device was changed to architect i2000sr, list 3m74 (irving, tx as manufacturing site) and submitted under manufacturer report number 3016438761-2020-00172.All further information will be documented under mdr number 3016438761-2020-00172.

• Brand Name: ARCHITECT HBSAG QUALITATIVE
• Common Device Name: HBSAG
• Manufacturer (Section D): ABBOTT IRELAND DIAGNOSTICS DIVISION; finisklin business park; diagnostics division; sligo NA ; EI NA
• MDR Report Key: 10288797
• Report Number: 3008344661-2020-00059
• Device Sequence Number: 19394706
• Product Code: LOM
• UDI-Device Identifier: 00380740007782
• UDI-Public: 00380740007782
• Combination Product (Y/N): N
• Initial Reporter State: AL
• 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): 08/14/2020

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 Model Number: 4P53-35
• Device Catalogue Number: 04P53-35
• Device Lot Number: 10262FN00
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 06/25/2020
• Supplement Date Received by Manufacturer: 07/27/2020
• Initial Report FDA Received Date: 07/17/2020
• Supplement Report FDA Received Date: 08/14/2020
• 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 LIST 03M74-02; ARCHITECT I2000SR ANALYZER LIST 03M74-02; SERIAL (B)(6) ; SERIAL (B)(6)