MAUDE Adverse Event Report: ABBOTT GMBH ARCHITECT ANTI-HBC II; TEST, HEPATITIS B (B CORE, BE ANTIGEN, BE ANTIBODY, B CORE IGM)

Catalog Number 08L44-78

Device Problem False Negative Result (1225)

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

Event Date 06/16/2020

Event Type  malfunction  

Manufacturer Narrative

Patient identifier = (b)(6).This report is being filed on an international product, list number 8l44 that has a similar product distributed in the us, list number 6l22.The complaint investigation for (b)(6) results for one sample tested with the architect anti-hbc ii assay included a review of data and information provided by the customer, search for similar complaints, ticket trending review, labeling review, device history record review and inhouse testing of retained kits with the complaint lot number.Trending review determined no trends for the issue for the product.Return testing was not completed as returns were not available.Sensitivity testing was performed with a retained kit of lot 05302be01 and determined that the sensitivity performance is not negatively impacted.Device history record review did not identify any non-conformances or deviations with the lot for the complaint issue.A review of the product labeling concluded that the issue is sufficiently addressed.Based on the investigation no product deficiency was identified for the architect anti-hbc ii assay, lot 05302be01.

Event Description

The customer reported a (b)(6) architect (b)(6) result on one patient.The results provided were: (b)(6) 2020 (b)(6) initial = (b)(6), retest = (b)(6).There was no additional patient information provided.

• Brand Name: ARCHITECT ANTI-HBC II
• Type of Device: TEST, HEPATITIS B (B CORE, BE ANTIGEN, BE ANTIBODY, B CORE IGM)
• Manufacturer (Section D): ABBOTT GMBH; max-planck-ring 2; wiesbaden 65205 ; GM 65205
• Manufacturer (Section G): ABBOTT GMBH; max-planck-ring 2; wiesbaden 65205 ; GM 65205
• Manufacturer Contact: christian lee ; 100 abbott park road; dept 09b9, bldg cp01-3; abbott park, IL 60064-3537 ; 224668-294
• MDR Report Key: 10233534
• MDR Text Key: 199827962
• Report Number: 3002809144-2020-00546
• 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: 07/06/2020

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 Expiration Date: 06/26/2020
• Device Catalogue Number: 08L44-78
• Device Lot Number: 05302BE01
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 06/16/2020
• Initial Date FDA Received: 07/06/2020
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 07/17/2019
• 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