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

Catalog Number 01R64-32

Device Problem False Positive Result (1227)

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

Event Date 01/25/2024

Event Type  malfunction  

Manufacturer Narrative

A1 - patient identifier: (b)(6) (4 different patients).All available patient information was included.Additional patient details are not available.This report is being filed on an international product, list number 01r64-32 that has a similar product distributed in the us, list number 01r64-21/-31.An evaluation is in process.A follow-up report will be submitted when the evaluation is complete.This submission is related to mfr # 3008344661-2024-00017-00.

Event Description

The customer observed false reactive alinity i hbsag next qualitative results for 4 patient samples.The following data was provided (reference range: < 1.00 s/co is nonreactive, >/= 1.00 s/co is reactive): on (b)(6) 2024 sid (b)(6) : initial result from aliquot on (b)(6) = 3.27 s/co; repeat results after centrifuging = 3.17 and 3.15 s/co; repeat result from original tube = 3.32; repeat result on (b)(6) = 2.83 s/co; result from original tube after maintenance on (b)(6) 2024 = 2.82 s/co; result from aliquot after maintenance = 3.22; result from edta plasma specimen = 2.63 s/co; hbsag neutralizing confirmatory test result = confirmed; hbeag result = 0.422 s/co; pcr result = negative on (b)(6) 2024 sid (b)(6) : initial result from aliquot = 5.48 s/co; repeat results after centrifuging the aliquot = 5.37 and 5.43 s/co; result from original tube = 5.78 s/co; result from another instrument (b)(6) = 6.31 s/co; result after recalibration on (b)(6) 2024 = 4.83 s/co; result from original after maintenance = 5.79 s/co; result from aliquot after maintenance = 5.68 s/co; hbsag neutralizing confirmatory test result = confirmed; hbeag result = 0.427 s/co (no pcr testing performed) on (b)(6) 2024 sid (b)(6) : initial result from aliquot = 8.42 s/co; repeat results after centrifuging the aliquot = 6.14 and 6.11 s/co; result from original tube = 6.87 s/co; repeat result ran on another analyzer (b)(6) = 1.43 s/co; result after calibration on (b)(6) 2024 = 3.04 s/co; result from original tube after maintenance on (b)(6) 2024 = 1.41s/co; result from aliquot tube after maintenance = 2.35 s/co; hbsag neutralizing confirmatory test result = confirmed; hbeag result = 0.399 s/co (no pcr testing performed) on (b)(6) 2024 sid (b)(6) : initial result from aliquot = 5.46 s/co; repeat results after centrifuging the aliquot = 4.66 and 5.14 s/co; result from original tube = 4.79 s/co; result from original tube after maintenance on (b)(6)2024 = 4.54 s/co; no testing done on aliquot after maintenance as there was no material left to test.Hbsag neutralizing confirmatory test result = confirmed; hbeag result = 0.358 s/co (no pcr testing performed) the customer stated the repeat reactive results generated did not correlate with the patients¿ clinical history.There was no impact to patient management reported.

Event Description

The customer observed false reactive alinity i hbsag next qualitative results for 4 patient samples.The following data was provided (reference range: < 1.00 s/co is nonreactive, >/= 1.00 s/co is reactive): on (b)(6) 2024 sid (b)(6): initial result from aliquot on (b)(6) = 3.27 s/co; repeat results after centrifuging = 3.17 and 3.15 s/co; repeat result from original tube = 3.32; repeat result on (b)(6) = 2.83 s/co; result from original tube after maintenance on (b)(6) 2024 = 2.82 s/co; result from aliquot after maintenance = 3.22; result from edta plasma specimen = 2.63 s/co; hbsag neutralizing confirmatory test result = confirmed; hbeag result = 0.422 s/co; pcr result = negative.On (b)(6) 2024 sid (b)(6): initial result from aliquot = 5.48 s/co; repeat results after centrifuging the aliquot = 5.37 and 5.43 s/co; result from original tube = 5.78 s/co; result from another instrument (b)(6) = 6.31 s/co; result after recalibration on (b)(6) 2024 = 4.83 s/co; result from original after maintenance = 5.79 s/co; result from aliquot after maintenance = 5.68 s/co; hbsag neutralizing confirmatory test result = confirmed; hbeag result = 0.427 s/co (no pcr testing performed).On (b)(6) 2024 sid (b)(6): initial result from aliquot = 8.42 s/co; repeat results after centrifuging the aliquot = 6.14 and 6.11 s/co; result from original tube = 6.87 s/co; repeat result ran on another analyzer (b)(6)= 1.43 s/co; result after calibration on (b)(6) 2024 = 3.04 s/co; result from original tube after maintenance on (b)(6) 2024 = 1.41s/co; result from aliquot tube after maintenance = 2.35 s/co; hbsag neutralizing confirmatory test result = confirmed; hbeag result = 0.399 s/co (no pcr testing performed).On (b)(6) 2024 sid (b)(6): initial result from aliquot = 5.46 s/co; repeat results after centrifuging the aliquot = 4.66 and 5.14 s/co; result from original tube = 4.79 s/co; result from original tube after maintenance on (b)(6) 2024 = 4.54 s/co; no testing done on aliquot after maintenance as there was no material left to test.Hbsag neutralizing confirmatory test result = confirmed; hbeag result = 0.358 s/co (no pcr testing performed).The customer stated the repeat reactive results generated did not correlate with the patients¿ clinical history.There was no impact to patient management reported.

Manufacturer Narrative

The complaint investigation 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.Return testing was not completed as returns were not available.Data and information provided by the customer were reviewed and support the complaint issue without indication for any additional issue.The lot search review did not identify an increase in complaint activity for the issue for the lot.A review of ticket tracking and trending did not identify any trends regarding the commonalities for the lot 54190fn00 and complaint issue.A review of the device history record was completed and did not identify any non-conformances, potential non-conformances or deviations associated with the lot 54190fn00 and complaint issue.Clinical specificity testing was performed using an in-house retained kit of complaint lot 54190fn00 stored at the recommended storage condition.All specifications were met indicating that the lots are performing acceptably.Labeling was reviewed and adequately addresses the issue under review.Based on the investigation, no systemic issue or product deficiency was identified for the alinity i hbsag next qualitative reagent lot 54190fn00.

• Brand Name: ALINITY I HBSAG NEXT QUALITATIVE 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: 18678343
• MDR Text Key: 335088628
• Report Number: 3008344661-2024-00016
• Device Sequence Number: 1
• Product Code: LOM
• Combination Product (y/n): N
• Reporter Country Code: GM
• 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: 04/01/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/09/2024
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 01R64-32
• Device Lot Number: 54190FN00
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 03/26/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 08/05/2023
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: ALNTY I HBSAG NXT CONF, 01R65-22, 52151FN00; ALNTY I HBSAG NXT CONF, 01R65-22, 52151FN00; ALNTY I PROCESSING MODU, 03R65-01, (B)(6); ALNTY I PROCESSING MODU, 03R65-01, (B)(6); ALNTY I PROCESSING MODU, 03R65-01, (B)(6); ALNTY I PROCESSING MODU, 03R65-01, (B)(6)