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

Model Number 4P53-35

Device Problem False Positive Result (1227)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 06/11/2020

Event Type  malfunction  

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 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.

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
• Type of Device: HBSAG
• Manufacturer (Section D): ABBOTT IRELAND DIAGNOSTICS DIVISION; finisklin business park; diagnostics division; sligo NA ; EI NA
• MDR Report Key: 10288797
• MDR Text Key: 233701095
• Report Number: 3008344661-2020-00059
• Device Sequence Number: 1
• Product Code: LOM
• UDI-Device Identifier: 00380740007782
• UDI-Public: 00380740007782
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional
• Type of Report: Initial,Followup
• Report Date: 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
• Device Operator: Health Professional
• Device Model Number: 4P53-35
• Device Catalogue Number: 04P53-35
• Device Lot Number: 10262FN00
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 06/25/2020
• Initial Date FDA Received: 07/17/2020
• Supplement Dates Manufacturer Received: 07/27/2020
• Supplement Dates FDA Received: 08/14/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: ARCHITECT I2000SR ANALYZER LIST 03M74-02; ARCHITECT I2000SR ANALYZER LIST 03M74-02; SERIAL (B)(6) ; SERIAL (B)(6)