MAUDE Adverse Event Report: ABBOTT IRELAND ARCHITECT HBSAG REAGENT KIT TEST, HEPATITIS B (B CORE, BE ANTIGEN, BE ANTIBODY, B CORE IGM)

Catalog Number 06C36-76

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, architect (b)(6), list 6c36, that has a similar product distributed in the us, list number 4p53. An evaluation is in process. A follow-up report will be submitted when the evaluation is complete. Additional information section 1 patient information: patient 1 - (b)(6) year old male. Patient 2 - (b)(6) year old male. Patient 3 - (b)(6) year old male. Patient 4 - (b)(6) year old female.

Event Description

The customer obtained false negative architect (b)(6) results for four samples. The customer indicated the samples were positive for dna. The following results were provided: patient 1 - (b)(6) year old male with chronic (b)(6): 0 and 0. 01 iu/ml on two architect analyzers and 0 iu/ml on alinity (b)(6). Patient 2 - (b)(6) year old male with liver fibrosis: 0. 04 and 0. 02 iu/ml on two architect analyzers; alinity (b)(6). Patient 3 - (b)(6) year old male with liver transplant: 0 and 0 iu/ml on two architect analyzers and 0 iu/ml on alinity (b)(6). Patient 4 - (b)(6) year old female with chronic (b)(6): 0. 03 and 0. 02 iu/ml on two architect analyzers and 0. 02 iu/ml on the alinity (b)(6). No impact to patient management was reported.

• Brand Name: ARCHITECT HBSAG REAGENT KIT
• Type of Device: TEST, HEPATITIS B (B CORE, BE ANTIGEN, BE ANTIBODY, B CORE IGM)
• Manufacturer (Section D): ABBOTT IRELAND; finisklin business park; sligo F91VY 44; EI F91VY44
• Manufacturer (Section G): ABBOTT IRELAND; finisklin business park; sligo F91VY 44; EI F91VY44
• Manufacturer Contact: christian lee ; 100 abbott park road; dept. 09b9, lc cp01-3; abbott park, IL 60064-3537 ; 2246682940
• MDR Report Key: 10823560
• MDR Text Key: 249659836
• Report Number: 3008344661-2020-00107
• Device Sequence Number: 1
• Product Code: LOL
• Combination Product (y/n): N
• Reporter Country Code: CH
• PMA/PMN Number: N/A
• 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,Followup
• Report Date: 02/10/2021

1 Device was Involved in the Event

0 Patients were Involved in the Event:

• Date FDA Received: 11/11/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes

Device Operator

• Device Expiration Date: 03/18/2021
• Device Catalogue Number: 06C36-76
• Device Lot Number: 14116FN00
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes

Was the Report Sent to FDA?

• Event Location: No Information
• Date Manufacturer Received: 02/04/2021
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 04/11/2020
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No

Type of Device Usage