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

Catalog Number	06L22-25
Medical Device Problem Code	False Negative Result (1225)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/24/2023
Type of Reportable Event	Malfunction
Event or Problem Description
The customer observed a false nonreactive architect core result for one sample.The following data was provided: 24aug2023: anti-hbcore total result = 0.08 (nonreactive).Anti-hbcore igm result = 11, repeat = 12 (reactive).The physician is questioning the result since the anti-hbcore total result is less than the anti-hbcore m result.The sample was repeated on 13sep2023 and generated the same results.No impact to patient management was reported.
Additional Manufacturer Narrative
An evaluation is in process.A follow-up report will be submitted when the evaluation is complete.
Event or Problem Description
The customer observed a false nonreactive architect core result for one sample.The following data was provided: 24aug2023: anti-hbcore total result = 0.08 (nonreactive).Anti-hbcore igm result = 11, repeat = 12 (reactive).The physician is questioning the result since the anti-hbcore total result is less than the anti-hbcore m result.The sample was repeated on 13sep2023 and generated the same results.No impact to patient management was reported.
Additional Manufacturer Narrative
Section d4 lot # has been updated from 50558be00 to 50607be00.Section g1 has been updated to current contact information.H3 other text : device evaluation still in process.
Event or Problem Description
The customer observed a false nonreactive architect core result for one sample.The following data was provided: (b)(6) 2023: anti-hbcore total result = 0.08 (nonreactive) anti-hbcore igm result = 11, repeat = 12 (reactive) the physician is questioning the result since the anti-hbcore total result is less than the anti-hbcore m result.The sample was repeated on (b)(6) 2023 and generated the same results.No impact to patient management was reported.
Additional Manufacturer Narrative
The complaint investigation for false nonreactive architect core results 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 in house testing.Additionally return sample testing was conducted.Data and information provided by the customer were reviewed and support the complaint issue without indication for any additional issue.A search for similar complaints did not identify an increase in complaint activity.A review of tracking and trending did not identify any trends for the product for the issue.Device history record review did not identify any non-conformances or deviations associated with lot number 50607be00 and the complaint issue.In-house sensitivity testing was completed using an in-house retained kit with complaint lot number 50607be00.All controls met specifications and no false non-reactive results were obtained.The complaint lot detected the same bleeds of the seroconversion panels as reactive, as per the manufacturer data.Labeling was reviewed and found to adequately address the issue under review.The volume of the return sample was not sufficient to execute the complete test protocol as only 80 l were available for testing.Therefore, only the first test of the schedule (alinity s anti-hbc) was performed.Result for sample (b)(6) with alinity s anti-hbc generated a nonreactive result (0.13 s/co), and thus interpretation was in alignment with the customer result.A final disposition for the return sample was not possible due to the test algorithm not being completed.Based on the investigation, no systemic issue or deficiency of the architect core for lot number 50607be00 was identified.

• Brand Name: ARCHITECT CORE REAGENT KIT
• Common Device Name: 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: 17870991
• Report Number: 3002809144-2023-00417
• Device Sequence Number: 5953605
• Product Code: LOM
• UDI-Device Identifier: 00380740011123
• UDI-Public: 00380740011123
• Combination Product (Y/N): N
• Initial Reporter State: IL
• Initial Reporter Country: US
• PMA/510(K) Number: P080023
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 01/04/2024

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
• Operator of Device: Health Professional
• Device Expiration Date: 03/16/2024
• Device Catalogue Number: 06L22-25
• Device Lot Number: 50607BE00
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 09/14/2023
• Supplement Date Received by Manufacturer: 10/18/2023; 01/04/2024
• Initial Report FDA Received Date: 10/04/2023
• Supplement Report FDA Received Date: 11/07/2023; 01/04/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 03/31/2023
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: ARC I2000SR INST, 03M74-02, (B)(6); ARC I2000SR INST, 03M74-02, (B)(6); ARC I2000SR INST, 03M74-02, (B)(6)
• Patient Sex: Unknown