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 08L44-25

Device Problem False Negative Result (1225)

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

Event Date 09/22/2023

Event Type  malfunction  

Event Description

The customer reported a false nonreactive architect anti-hbc ii result on a patient.The following results were provided: aug2019 anti-hbc = 8.52 s/co.(b)(6) 2023 anti-hbc = 0.56 s/co; hbsab = 108.76 miu/ml (positive).(b)(6) 2023 anti-hbc = 6.26 s/co; hbsab = 154.06 miu/ml (positive).No impact to patient management was reported.

Manufacturer Narrative

An evaluation is in process.A follow up report will be submitted when the evaluation is complete.This report is being filed on an international product, list number 8l44 that has a similar product distributed in the us, list number 6l22.

Manufacturer Narrative

The evaluation of complaint data for the product and likely cause lot 49777be00 identified normal complaint activity.No customer returns were available for evaluation.Manufacturing documentation for the likely cause lot did not identify any issues associated with the complaint issue.The performance of the likely cause lot was investigated by completing a review for non-conformances, potential non-conformances and deviations related to the likely cause lot.This review did not identify any non-conformances, potential non-conformances, or deviations.As part of the complaint overall investigation, an evaluation of lot 49777be00 clinical sensitivity was performed which demonstrated acceptable sensitivity per specifications, confirming that this lot is meeting the architect anti-hbc ii product requirement.A review of the product labeling concluded that the issue is sufficiently addressed.No systemic issue or product deficiency was identified.

Event Description

The customer reported a false nonreactive architect anti-hbc ii result on a patient.The following results were provided: aug2019 anti-hbc = 8.52 s/co.22sep2023 anti-hbc = 0.56 s/co; hbsab = 108.76 miu/ml (positive).12oct2023 anti-hbc = 6.26 s/co; hbsab = 154.06 miu/ml (positive).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 ; GM 65205 ; 6122582960
• MDR Report Key: 18067967
• MDR Text Key: 327318895
• Report Number: 3002809144-2023-00458
• Device Sequence Number: 1
• Product Code: LOM
• Combination Product (y/n): N
• Reporter Country Code: JA
• 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: 12/07/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/03/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 02/02/2024
• Device Catalogue Number: 08L44-25
• Device Lot Number: 49777BE00
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 12/07/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 02/22/2023
• 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, ISR60305; ARC I2K PROC MOD, 03M74-01, ISR60305