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

Catalog Number 07P87-77

Device Problem False Negative Result (1225)

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

Event Date 11/20/2023

Event Type  malfunction  

Event Description

The customer observed a false nonreactive alinity i anti-hbc ii result for one sample.The following data was provided: initial result = 0.77 s/co (nonreactive), repeat = 0.99 s/co (nonreactive), colloidal gold test = positive.Previous results from (b)(6) 2023 was 1.77 s/co (reactive).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 7p87 has a similar product distributed in the us, list number 7p84.

Manufacturer Narrative

The complaint investigation for false nonreactive alinity i anti-hbc ii 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.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 any increase in complaint activity for lot 53308be01.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 53308be01 and complaint issue.In-house testing of a retained kit of architect anti-hbc ii reagent, lot number 53308be00 was performed (alinity i anti-hbc ii and architect anti-hbc ii utilize the same reagents and sample/reagent ratios).All control values met control specifications and no false nonreactive results were obtained.In addition, the clinical sensitivity was evaluated by testing a commercially available seroconversion panel.The seroconversion panel results indicate that the sensitivity performance of the lot is not negatively impacted.Labeling was reviewed and found to be adequate.Based on the investigation, no systemic issue or deficiency with the alinity i anti-hbc ii reagent for lot 53308be01 was identified.

Event Description

The customer observed a false nonreactive alinity i anti-hbc ii result for one sample.The following data was provided: initial result = 0.77 s/co (nonreactive), repeat = 0.99 s/co (nonreactive), colloidal gold test = positive previous results from (b)(6)2023 was 1.77 s/co (reactive) no impact to patient management was reported.

• Brand Name: ALINITY I 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: 18249268
• MDR Text Key: 329509319
• Report Number: 3002809144-2023-00482
• 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: 02/06/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/01/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 07P87-77
• Device Lot Number: 53308BE01
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 02/06/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 07/20/2023
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: ALNTY I PROCESSING MODU, 03R65-01, (B)(6); ALNTY I PROCESSING MODU, 03R65-01, (B)(6)