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 09/01/2023

Event Type  malfunction  

Event Description

A literature article by alkhazashvili, maia, et al., ¿advancing blood transfusion safety using molecular detection in the country georgia¿, transfusion clinique et biologique 30.3: 307-313.Elsevier masson s.R.L.(aug 2023), performed a study that documented false negative architect anti-hbc ii results.The multiplex nat (nucleic acid amplification test) testing generated positive samples that were in discordance with the initial serology testing (non-abbott platform).The sixty discordant donor samples were retested for architect anti-hbc ii on the architect i2000sr analyzer.Repeat testing of these 60 donor samples were completed.The study noted 12 donors were positive for nat (nucleic acid amplification test) testing but 6 of those samples generated negative results when using the architect anti-hbc ii assay.There was no impact to patient management reported.

Manufacturer Narrative

All available patient information was included.Additional patient details are not available.E1 - postal code: a leading zero was added to the field because the system requires a minimum of 5 digits in the postal code field.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.

Event Description

A literature article by alkhazashvili, maia, et al., ¿advancing blood transfusion safety using molecular detection in the country georgia¿, transfusion clinique et biologique 30.3: 307-313.Elsevier masson s.R.L.(aug 2023), performed a study that documented false negative architect anti-hbc ii results.The multiplex nat (nucleic acid amplification test) testing generated positive samples that were in discordance with the initial serology testing (non-abbott platform).The sixty discordant donor samples were retested for architect anti-hbc ii on the architect i2000sr analyzer.Repeat testing of these 60 donor samples were completed.The study noted 12 donors were positive for nat (nucleic acid amplification test) testing but 6 of those samples generated negative results when using the architect anti-hbc ii assay.There was no impact to patient management reported.

Manufacturer Narrative

The complaint investigation for false nonreactive architect anti-hbc ii results included a search for similar complaints, and the review of complaint text, trending data, labeling, and device history records.Return testing was not performed as returns were not available.A review of tracking and tending of complaint data did not identify any related trends for the product for the issue.A review of the device history record did not identify any non-conformances or deviations associated with the complaint issue.Labeling was reviewed and concludes that the issue is adequately addressed.In this case, the donations were possibly collected during the ¿window period¿ prior to seroconversion.In the early phase of seroconversion nat testing (hbv dna detection) is positive, but serological antibody testing is nonreactive.No information was provided that any other method than nat provided reactive results for these samples.Based on the investigation, architect anti-hbc ii assay is performing as intended, no systemic issue or product deficiency was identified.Section g1 contact information was updated to reflect the current contact (b)(6).

• 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: 17785767
• MDR Text Key: 323902721
• Report Number: 3002809144-2023-00400
• Device Sequence Number: 1
• Product Code: LOM
• Combination Product (y/n): N
• Reporter Country Code: GG
• PMA/PMN Number: N/A
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Literature,Health Professional
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 10/30/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/20/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 08L44-25
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 10/23/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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, 116UNKNOWND11; ARC I2K PROC MOD, 03M74-01, 116UNKNOWND11