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

Catalog Number 07C18-78

Device Problem False Positive Result (1227)

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

Event Date 01/14/2020

Event Type  malfunction  

Manufacturer Narrative

This event is being filed on an international product, list 07c18-78, that has a same/similar us product, list 1l82.An investigation was performed for the customer issue and included a review of the complaint text, a search for similar complaints, a review of trending data, a review of the field data, and a review of product labeling.Ticket searches determined normal complaint activity for the likely cause lot.The complaint trending report review did not identify any trends for the issue for the product.Customer field data was used to assess the performance of the architect anti-hbs assay using world wide data.The median population result for the lot is comparable with all other lots in the field and confirms no systemic issue for the lot.Manufacturing documentation was reviewed and did not identify any issues.Labeling was reviewed and found to be adequate.Based on all available information and abbott diagnostics' complaint investigation a product deficiency was not identified.

Event Description

The customer reported a false reactive anti-hbs result, for a (b)(6) year old male patient with a history of (b)(6), when processing on the architect i2000sr.The sample generated a result of less than 1000 on the architect and non-reactive on the autobio assay.The customer stated the sample was also tested on an alinity and generated the same result as the architect.Additional diagnostic testing was provided for the patient hbsag (268.27), hbeag (0.450 s/co), and anti-hbc (9.60 s/co).No impact to patient management was reported.

• 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
• Manufacturer (Section G): ABBOTT IRELAND DIAGNOSTICS DIVISION; finisklin business park; diagnostics division; sligo NA ; EI NA
• Manufacturer Contact: christian lee ; 100 abbott park road; dept 09b9, bldg cp01-3; abbott park, IL 60064-3537 ; 224668-294
• MDR Report Key: 9716981
• MDR Text Key: 220247702
• Report Number: 3008344661-2020-00015
• Device Sequence Number: 1
• Product Code: LOM
• Combination Product (y/n): N
• Reporter Country Code: CH
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 02/17/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/17/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 08/13/2020
• Device Catalogue Number: 07C18-78
• Device Lot Number: 04319FN00
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 01/20/2020
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 06/14/2019
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Age: 64 YR