MAUDE Adverse Event Report: ABBOTT IRELAND DIAGNOSTICS DIVISION ARCHITECT ANTI-HBS

Catalog Number 07C18-41

Device Problem High Test Results (2457)

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

Event Type  malfunction  

Manufacturer Narrative

All available patient information was included.Additional patient details are not available.An evaluation is in process.A final report will be submitted when the evaluation is complete.This report is being filed on an international product, architect (b)(4), that has a similar product distributed in the us, (b)(4).

Event Description

The customer observed a (b)(6) anti-hbs result for one patient on the architect i2000sr analyzer.The following data was provided for a (b)(6) cancer patient: initial 53 miu/ml, repeated on another method as negative.There was no impact to patient management reported.

Manufacturer Narrative

Further investigation of the customer issue included a review of the complaint text, a search for similar complaints, review of instrument logs, a review of labeling, review of field data and specificity testing.No adverse trend was identified for the customer's issue.Labeling was reviewed and found to be adequate.No return patient sample was available.A significant value decrease was observed during antigen addition testing indicating possible interference in the specimen and it is possible that the anti-hbs result of 53miu/ml is a true positive result.Clinical specificity testing of negative panel replicates was performed using in-house retained kits stored at the recommended storage condition.Specificity testing met all specifications.Based on all available information and abbott diagnostics' complaint investigation no product deficiency was identified.

• Brand Name: ARCHITECT ANTI-HBS
• Type of Device: ANTI-HBS
• Manufacturer (Section D): ABBOTT IRELAND DIAGNOSTICS DIVISION; finisklin business park; diagnostics division; sligo NA ; EI NA
• MDR Report Key: 9569041
• MDR Text Key: 198750697
• Report Number: 3008344661-2020-00003
• 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: 02/25/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/09/2020
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 06/06/2020
• Device Catalogue Number: 07C18-41
• Device Lot Number: 02262FN00
• Was Device Available for Evaluation?: Yes
• Date Manufacturer Received: 02/25/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: ARCHITECT I2000SR ANALYZER; ARCHITECT I2000SR ANALYZER; LN 03M74-01 SN (B)(6) ; LN 03M74-01 SN (B)(6)
• Patient Age: 58 YR