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.

Manufacturer Narrative

The complaint investigation included a search for similar complaints, and review of complaint text, trending data, labeling, and device history records.In-house testing of reagent lot 14116fn00 was also completed.Return testing was not completed as returns were not available.Review of trending data did not identify any trends for the issue.Device history record review for reagent lot 14116fn00 did not identify any potential non-conformances, or deviations.Labeling was reviewed and found to adequately address the issue under review.In house testing of panels which mimic patient samples was completed using retained kits of the complaint lot.All specifications were met indicating that the lot is performing acceptably.Based on the investigation, no systemic issue or deficiency of the architect hbsag assay, lot number 14116fn00 was identified.

Event Description

The customer obtained false negative architect hbsag results for four samples.The customer indicated the samples were positive for dna.The following results were provided: patient 1 - 54 year old male with chronic hepatitis b: 0 and 0.01 iu/ml on two architect analyzers and 0 iu/ml on alinity hbsag.Hbeab and hbcab and dna positive.Patient 2 - 30 yea old male with liver fibrosis: 0.04 and 0.02 iu/ml on two architect analyzers; alinity hbsag 0.05 iu/ml positive, hbeag, hbcab and dna positive patient 3 - 54 year old male with liver transplant: 0 and 0 iu/ml on two architect analyzers and 0 iu/ml on alinity hbsag; positive results for hbsab, hbeab, hbcab and dna.Patient 4 - 32 year old female with chronic hepatitis b: 0.03 and 0.02 iu/ml on two architect analyzers and 0.02 iu/ml on the alinity hbsag; positive results for hbcab and dna.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
• 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
• PMA/PMN Number: N/A
• 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: 02/10/2021

1 Device was Involved in the Event

1 Patient was 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: Health Professional
• Device Expiration Date: 03/18/2021
• Device Catalogue Number: 06C36-76
• Device Lot Number: 14116FN00
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 02/04/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: ARC I2K PROC MOD, 03M74-01, (B)(6) ; ARC I2K PROC MOD, 03M74-01, (B)(6)