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

Catalog Number 08L44-30

Device Problem False Negative Result (1225)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 07/25/2023

Event Type  malfunction  

Manufacturer Narrative

This report is being filed on an international product, architect anti-hbc ii, list number 08l44-30, that has a similar product distributed in the us, list number 06l22.An evaluation is in process.A follow-up report will be submitted when the evaluation is complete.

Event Description

The customer observed false nonreactive architect anti-hbc ii result for one patient who is known to be reactive.The sample was repeated, and the results were reactive.The following data was provided: (b)(6) 2023 sid (b)(6) initial result = 0.34 s/co (nonreactive).(b)(6) 2023 repeat result (on the same analyzer) = 2.12 s/co (reactive).(b)(6) 2023 repeat result (different analyzer) = 2.08 s/co (reactive).No impact to patient management was reported.

Manufacturer Narrative

The complaint investigation for false non-reactive architect anti-hbc ii result included a review of data and information provided by the customer, instrument log review, search for similar complaints, ticket trending review, device history record review, and labeling review.In-house testing of retained reagent kit was also completed.Return testing was not completed as returns were not available.Data and information provided by the customer were reviewed and support the complaint issue.A review of the customer¿s instrument log was performed.An analysis of pressure monitoring data suggests higher viscosity in the initial test (non-reactive result), which might be due to particulate matter or might indicate that sample tested on (b)(6) 2023 is not identical to the sample tested on (b)(6) 2023.Therefore, sample integrity issues at the time of testing could have contributed to the customer¿s observation.Ticket search by lot indicates that the reagent lot performs as expected for this product.Trending review did not identify any trends for the issue for the product.Device history record review did not identify any non-conformances or deviations with lot number 50549be00 and complaint issue.Labeling was reviewed and sufficiently addresses the customer's issue.In-house testing of a retained reagent kit of the complaint lot was performed.All specifications were met and no false non-reactive results were obtained, indicating that the lot generates the expected results.The clinical sensitivity of the lot was evaluated by testing two commercially available seroconversion panels (biomex seroconversion panel scp-hbv-001 and scp-hbv-004).The seroconversion panel results were compared to architect anti-hbc ii test results provided by biomex.The lot detected the same bleeds as reactive for the seroconversion panels.These data indicated that the sensitivity performance of the complaint lot is not adversely affected.Based on this investigation, no systemic issue or deficiency with the architect anti-hbc ii reagent, lot number 50549be00 was identified.The following sections have been corrected to reflect the current contact (b)(6): g1-contact office first name g1-contact office last name g1-contact office address 1 g1-contact office city g1-contact office postal code g1-contact office country g1-contact office phone number g1-contact office email g1-contact office fax number.

Event Description

The customer observed false nonreactive architect anti-hbc ii result for one patient who is known to be reactive.The sample was repeated, and the results were reactive.The following data was provided: (b)(6) 2023 sid (b)(6) initial result = 0.34 s/co (nonreactive) (b)(6) 2023 repeat result (on the same analyzer) = 2.12 s/co (reactive) (b)(6) 2023 repeat result (different analyzer) = 2.08 s/co (reactive) no impact to patient management was reported.

• Brand Name: ARCHITECT ANTI-HBC II REAGENT KIT
• 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: nicole jenne ; max-planck-ring 2; post market surveillance; wiesbaden 65205 ; EI 65205 ; 6122582960
• MDR Report Key: 17597530
• MDR Text Key: 321678678
• Report Number: 3002809144-2023-00364
• Device Sequence Number: 1
• Product Code: LOM
• Combination Product (y/n): N
• Reporter Country Code: EI
• 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: 10/13/2023

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: 03/15/2024
• Device Catalogue Number: 08L44-30
• Device Lot Number: 50549BE00
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 08/03/2023
• Initial Date FDA Received: 08/22/2023
• Supplement Dates Manufacturer Received: 10/11/2023
• Supplement Dates FDA Received: 10/13/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 04/04/2023
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: ARC I2K PROC MOD, 03M74-01, ISR04288; ARC I2K PROC MOD, 03M74-01, ISR04288