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

Catalog Number 06C36-44

Device Problem False Negative Result (1225)

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

Event Type  malfunction  

Manufacturer Narrative

This report is being filed on an international product list 6c36, that has a similar us product distributed in the us, list 4p53.An evaluation is in process.A follow up report will be submitted when the evaluation is completed.

Event Description

The account questioned a (b)(6) architect (b)(6) on patient who tested (b)(6).The sample repeated architect (b)(6).The (b)(6) architect (b)(6) result was not reported out of the laboratory.The account sent the sample to reference labs with both (b)(6).The patient is of (b)(6) ethnicity.No impact to patient management was reported.

Manufacturer Narrative

Upon retrospective review, it was discovered that the manufacturer name, city and state (section d.3 and g.1.2) on manufacturing report number 3005094123-2020-00132 listed as (b)(4) was incorrect.The correct manufacturer name, city and state is (b)(4).All further information will be documented under mdr number 3008344661-2020-00062.

• Brand Name: ARCHITECT HBSAG
• Type of Device: HBSAG
• Manufacturer (Section D): ABBOTT IRELAND DIAGNOSTICS DIVISION LONGFORD; lisnamuck; co. longford; longford NA ; EI NA
• MDR Report Key: 10182589
• MDR Text Key: 199460999
• Report Number: 3005094123-2020-00132
• Device Sequence Number: 1
• Product Code: LOM
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional
• Type of Report: Initial,Followup
• Report Date: 08/13/2020

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 Catalogue Number: 06C36-44
• Device Lot Number: 06418FN00
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 06/07/2020
• Initial Date FDA Received: 06/22/2020
• Supplement Dates Manufacturer Received: 08/13/2020
• Supplement Dates FDA Received: 08/13/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: ARCHITECT I2000SR LIST 03M74-02; ARCHITECT I2000SR LIST 03M74-02; SERIAL (B)(6); SERIAL(B)(6)
• Patient Age: 34 YR