MAUDE Adverse Event Report: ABBOTT IRELAND DIAGNOSTICS DIVISION ALINITY I HBSAG QUALITATIVE II REAGENT KIT; TEST, HEPATITIS B (B CORE, BE ANTIGEN, BE ANTIBODY, B CORE IGM)

Catalog Number 08P10-32

Device Problem False Positive Result (1227)

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

Event Date 01/23/2024

Event Type  malfunction  

Event Description

The customer observed false reactive results for alinity i hbsag qualitative ii and alinity i hbsag qualitative ii confirmatory for one patient.The alinity i hbsag qualitative ii test was repeated with different samples from the same patient and the results were nonreactive.The original sample was repeated on another alinity with reactive results.The following data was provided: original draw was on (b)(6) 2024 with three tubes: sid (b)(6) (reactive results), sid (b)(6) (nonreactive results) sid (b)(6) (nonreactive results).Sid (b)(6) processed initial results on (b)(6) 2024 on alinity serial number (b)(6): hbsag = 950.7; confirmatory = hbsagquac1 = 1.54 s/co hbsagquac2 = 788.91 s/co hbsagqua%n = 100 % neutralization.Sid (b)(6) repeat results on (b)(6) 2024 on alinity serial number (b)(6): hbsag = 1951.Sid (b)(6) processed on (b)(6) 2024 on alinity serial number (b)(6): hbsag = 0.46.Sid (b)(6) processed on (b)(6) 2024 on alinity serial number (b)(6): hbsag = 0.27.New draw on (b)(6) 2024 sid (b)(6) processed on alinity serial number (b)(6): hbsag = 0.29.Additional data provided 13feb2024; sid (b)(6) was processed with a new reagent lot 57450fn00 and result was positive.Sid (b)(6) which was negative is now positive with the new reagent lot number 57450fn00.Sid (b)(6) is still negative with the new lot.No impact to patient management was reported.

Manufacturer Narrative

Complete information for section a1 - patient identifier: sid (b)(6).All available patient information is included.Additional patient details are not available.This report is being filed on an international product, list number 8p10-32 that has a similar product distributed in the us, list number 8p10-21/-31.An evaluation is in process.A follow-up report will be submitted when the evaluation is complete.See mfr# 3008344661-2024-00018-00 for initial submission on alnty i hbs ag qual con, 08p11-22, 54084fn00.See mfr# 3008344661-2024-00019-00 for initial submission on alnty i hbsag qual 1200, 08p10-32.

Manufacturer Narrative

The complaint investigation for false reactive alinity i hbsag qualitative 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 field testing review.The ticket trending review of at least 12 months complaint data for the likely cause list numbers did not identify any trend regarding commonalities for complaint lots and issue.Device history record review did not identify any nonconformances or deviations associated with the likely cause lot numbers and the customer¿s issue.Historical performance in the field of reagent lots using worldwide data was evaluated.The patient median result for the lots is comparable with all other lots in the field and within established baselines, confirming no systemic issue for the product lots.Labeling was reviewed and found to be adequate.Based on our investigation, no systemic issue or deficiency with the alinity i hbsag qualitative ii reagent for lot numbers 55638fn00 and 57450fn00 was identified.

Event Description

The customer observed false reactive results for alinity i hbsag qualitative ii and alinity i hbsag qualitative ii confirmatory for one patient.The alinity i hbsag qualitative ii test was repeated with different samples from the same patient and the results were nonreactive.The original sample was repeated on another alinity with reactive results.The following data was provided: original draw was on (b)(6) 2024 with three tubes: sid (b)(6)(reactive results), sid (b)(6)(nonreactive results) sid (b)(6)(nonreactive results).Sid (b)(6) processed initial results on (b)(6) 2024 on on alinity serial number (b)(6): hbsag = 950.7.Confirmatory = hbsagquac1 = 1.54 s/co hbsagquac2 = 788.91 s/co hbsagqua%n = 100 % neutralization.Sid (b)(6) repeat results on (b)(6) 2024 on alinity serial number (b)(6): hbsag = 1951.Sid (b)(6) processed on (b)(6) 2024 on alinity serial number (b)(6): hbsag = 0.46.Sid (b)(6) processed on (b)(6) 2024 on alinity serial number (b)(6): hbsag = 0.27 new draw on (b)(6) 2024 sid (b)(6) processed on alinity serial number (b)(6): hbsag = 0.29.Additional data provided 13feb2024; sid (b)(6) was processed with a new reagent lot 57450fn00 and result was positive.Sid (b)(6) which was negative is now positive with the new reagent lot number 57450fn00.Sid (b)(6) is still negative with the new lot.No impact to patient management was reported.

• Brand Name: ALINITY I HBSAG QUALITATIVE II REAGENT KIT
• Type of Device: TEST, HEPATITIS B (B CORE, BE ANTIGEN, BE ANTIBODY, B CORE IGM)
• Manufacturer (Section D): ABBOTT IRELAND DIAGNOSTICS DIVISION; finisklin business park; sligo F91VY 44; EI F91VY44
• Manufacturer (Section G): ABBOTT IRELAND DIAGNOSTICS DIVISION; finisklin business park; sligo F91VY 44; EI F91VY44
• Manufacturer Contact: nicole jenne ; max-planck-ring 2; post market surveillance; wiesbaden 65205 ; GM 65205 ; 6122582960
• MDR Report Key: 18789500
• MDR Text Key: 336738171
• Report Number: 3008344661-2024-00025
• Device Sequence Number: 1
• Product Code: LOM
• Combination Product (y/n): N
• Reporter Country Code: GM
• PMA/PMN Number: P110029
• 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: 04/15/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/27/2024
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 08P10-32
• Device Lot Number: 57450FN00
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 04/12/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 11/28/2023
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: ALNTY I HBS AG QUAL CON, 08P11-22, 54084FN00; ALNTY I HBS AG QUAL CON, 08P11-22, 54084FN00; ALNTY I PROCESSING MODU, 03R65-01, (B)(6); ALNTY I PROCESSING MODU, 03R65-01, (B)(6)