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 08L44-78

Device Problem False Negative Result (1225)

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

Event Date 08/25/2023

Event Type  malfunction  

Event Description

The customer observed a false non-reactive architect anti-hbc ii result for a patient sample.The following data was provided: (b)(6) 2023.Sag result = 131.25 iu/ml (reference range <0.05 iu/ml).Sab result = <2.50 miu/ml (reference range <10 miu/ml).Eag result = 0.18 peiu/ml (quantitative test result) (reference range <0.11 peiu/ml).Eab result = 2.25 s/co (reference range >1.0 s/co).Cab result = 0.70 s/co, (b)(6) 2023 repeat result = 0.81 s/co (reference range <1.0 s/co).Patient¿s historical results: sag (b)(6) 2022 result = 354.0 iu/ml, (b)(6) 2022 result = 385.89 iu/ml, (b)(6) 2022 result = 484.98 iu/ml, sab (b)(6) 2022 result = <2.50 miu/ml, (b)(6) 2022 result = <2.50 miu/ml, (b)(6) 2022 result = <2.50 miu/ml, eag (b)(6) 2022 result = 0.42 peiu/ml, (b)(6) 2022 result = 0.38 peiu/ml, (b)(6) 2022 result = 0.34 peiu/ml (quantitative test results), eab (b)(6) 2022 result = 1.83 s/co, (b)(6) 2022 result = 2.17 s/co, (b)(6) 2022 result = 1.74 s/co, cab (b)(6) 2022 result = 1.48 s/co, (b)(6) 2022 result = 1.66 s/co, (b)(6) 2022 result = 1.25 s/co, no impact to patient management was reported.

Manufacturer Narrative

An evaluation is in process.A final report will be submitted when the evaluation is complete.Section e1 - facility name complete entry = (b)(6) hospital.Section e1 - address 1 complete entry = (b)(6) hospital.Section e1 - phone number complete entry = (b)(6).All available patient information was included.Additional patient details are not available.  this report is being filed on an international product, list number 8l44 that has a similar product distributed in the us, list number 6l22.

Event Description

The customer observed a false non-reactive architect anti-hbc ii result for a patient sample.The following data was provided: (b)(6) 2023, sag result = 131.25 iu/ml (reference range <0.05 iu/ml), sab result = <2.50 miu/ml (reference range <10 miu/ml), eag result = 0.18 peiu/ml (quantitative test result) (reference range <0.11 peiu/ml), eab result = 2.25 s/co (reference range >1.0 s/co), cab result = 0.70 s/co, (b)(6) 2023 repeat result = 0.81 s/co (reference range <1.0 s/co).Patient¿s historical results: sag (b)(6) 2022 result = 354.0 iu/ml, (b)(6) 2022 result = 385.89 iu/ml, (b)(6) 2022 result = 484.98 iu/ml.Sab (b)(6) 2022 result = <2.50 miu/ml, (b)(6) 2022 result = <2.50 miu/ml, (b)(6) 2022 result = <2.50 miu/ml.Eag (b)(6) 2022 result = 0.42 peiu/ml, (b)(6) 2022 result = 0.38 peiu/ml, (b)(6) 2022 result = 0.34 peiu/ml (quantitative test results).Eab (b)(6) 2022 result = 1.83 s/co, (b)(6) 2022 result = 2.17 s/co, (b)(6) 2022 result = 1.74 s/co.Cab (b)(6) 2022 result = 1.48 s/co, (b)(6) 2022 result = 1.66 s/co, (b)(6) 2022 result = 1.25 s/co.No impact to patient management was reported.

Manufacturer Narrative

The complaint investigation included a review of data and information provided by the customer, search for similar complaints, ticket trending review, labeling review, device history record review, in house testing of a retained reagent kit, and in house sensitivity testing.Return testing was not completed as returns were not available.Data and information provided by the customer were reviewed and support the complaint issue.Ticket search by lot indicated the reagent lot is performing as expected for this product.A review of tracking and trending did not identify any trends for the complaint issue.Device history record review did not identify any non-conformances or deviations with lot 48185be01 and the complaint 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.In addition, 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 test results provided by biomex.The lot detected the same bleeds as reactive for the seroconversion panels.Based on these data it was shown that the sensitivity performance of the complaint lot is not impacted.Labeling was reviewed and found to adequately address the issue under review.Based on this investigation, no systemic issue or deficiency with the architect anti-hbc ii reagent lot 48185be01, was identified.Updated information in section g1.

• 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 ; GM 65205 ; 6122582960
• MDR Report Key: 17697749
• MDR Text Key: 322811250
• Report Number: 3002809144-2023-00382
• Device Sequence Number: 1
• Product Code: LOM
• 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: 10/24/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/07/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 01/05/2024
• Device Catalogue Number: 08L44-78
• Device Lot Number: 48185BE01
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 10/24/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 02/20/2023
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: ARC I2000SR INST, 03M74-02, (B)(6) ; ARC I2000SR INST, 03M74-02, (B)(6)