MAUDE Adverse Event Report: ABBOTT MOLECULAR, INC. ABBOTT REALTIME HIV-1; TEST, HIV DETECTION

Catalog Number 02G31-010

Device Problem Low Test Results (2458)

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

Event Date 03/09/2023

Event Type  malfunction  

Manufacturer Narrative

An investigation has been initiated.A follow-up report will be sent once investigation is compete.This incident is being reported to fda because the incident occurred internationally using the abbott realtime hiv-1 assay, list number 02g31-010, which is the same/similar to the abbott realtime hiv-1 amplification reagent kit 06l18-090, which received fda approval under pma number bp060002.As the incident was reported to involve an additional device lot, report number 3005248192-2023-00194 has also been submitted as a related report.

Event Description

The customer reported performance issues while using the abbott realtime hiv-1 assay.The customer reported that they were experiencing quality control/assurance issues affecting hiv-1 viral load (vl) and proficiency testing during last 3 months.The customer noted the issue was experienced while using dried blood spots (dbs) as a sample type.The lab reported many failed runs and challenges in calibrating the instruments.The customer evaluated test runs from november 2022 to may 2023 and noticed poor test performance on specific lot numbers characterized by a delay in amplification curves.The customer noted that the impact of variation in precision and accuracy of viral load testing is significant for hiv patient's treatment management because the efficacy of treatment and viral suppression may not be accurately assessed and vl results may not correlate with the patient´s clinical presentation.The customer noted a recommendation of a performance evaluation of the affected kit lot numbers and of subsequent reagents before testing on clinical samples.On (b)(6) 2023, the customer clarified that the concern was not for internal control or fluorescence errors, but regarding performance of the reagent lot as the internal control for this assay in the customer's lab has historically amplified around 21-22 cycles, however with the current lot, internal controls were amplified between cycles 23-24.The customer noted their concern was that if the internal control was delayed, the same possibility existed for the patient samples and noted there was a concern for quantification to be lower than expected (falsely depressed results).It was noted that the customer was questioning approximately 20,000 tests generated between (b)(6) 2023 with the reagent lot(s) in question.The customer did not indicate any specific patient results in question or any retested results for the patients in question.The customer did not indicate the results considered to be correct, or the difference between the results generated and the anticipated results.The customer did not indicate any specific changed therapies.The customer did indicate a delay in generating results as the customer has been unable to generate results for approximately one month due to the investigation.The customer did not indicate any specific harm to any patient.The customer indicated in several instances that the national lab will analyze clinical impact and has not provided any further details related to the clinical impacts of this issue.

Event Description

The customer reported performance issues while using the abbott realtime hiv-1 assay.The customer reported that they were experiencing quality control/assurance issues affecting hiv-1 viral load (vl) and proficiency testing during last 3 months.The customer noted the issue was experienced while using dried blood spots (dbs) as a sample type.The lab reported many failed runs and challenges in calibrating the instruments.The customer evaluated test runs from november 2022 to may 2023 and noticed poor test performance on specific lot numbers characterized by a delay in amplification curves.The customer noted that the impact of variation in precision and accuracy of viral load testing is significant for hiv patient's treatment management because the efficacy of treatment and viral suppression may not be accurately assessed and vl results may not correlate with the patient´s clinical presentation.The customer noted a recommendation of a performance evaluation of the affected kit lot numbers and of subsequent reagents before testing on clinical samples.On 16 june 2023, the customer clarified that the concern was not for internal control or fluorescence errors, but regarding performance of the reagent lot as the internal control for this assay in the customer's lab has historically amplified around 21-22 cycles, however with the current lot, internal controls were amplified between cycles 23-24.The customer noted their concern was that if the internal control was delayed, the same possibility existed for the patient samples and noted there was a concern for quantification to be lower than expected (falsely depressed results).It was noted that the customer was questioning approximately 20,000 tests generated between march 9 to may 8, 2023 with the reagent lot in question.The customer did not indicate any specific patient results in question or any retested results for the patients in question.The customer did not indicate the results considered to be correct, or the difference between the results generated and the anticipated results.The customer did not indicate any specific changed therapies.The customer did indicate a delay in generating results as the customer has been unable to generate results for approximately one month due to the known issue/investigation.The customer did not indicate any specific harm to any patient.The customer indicated in several instances that the national lab will analyze clinical impact and has not provided any further details.It was further clarified on 6 jul 2023 that the customer was questioning both plasma and dbs sample types.

Manufacturer Narrative

Manufacturer's analysis of event: investigation into this complaint included an evaluation of retained material, a customer data review, quality data review, a complaint history review, and a labeling review.The results of the investigation are summarized as follows: retain evaluation: abbott realtime hiv-1 amplification reagent kit (list 02g31-010) lots 529905 and 531516 retain samples were tested.Testing included evaluation of the reagent lots under both the plasma and dbs sample types utilizing panel samples of known quantitation.The testing for both hiv-1 plasma and dbs does not show any indication that the abbott realtime hiv-1 amplification reagent kit (list 02g31-010) lots 531516 and 529905 is performing outside of established design performance specifications.The runs met the validity and acceptance criteria.No quantitation issues were observed with the reported lots.Additionally, median internal control (ic) of lots 531316 and 529905 were compared between qc release testing, tps testing and customer testing data for the plasma sample type.Based on the data analysis, there was no observable shift in the performance of the product (amp kit lot 531516 & 529905) when the product is stored as intended.The testing data demonstrated that there has been no degradation of the reagents over time for reagents stored as intended.A product deficiency was not identified by this evaluation.Customer data review: the review of the customer data demonstrated that the assay software is performing as expected.The calibrators and controls for the hiv-1 assay at the customer's site met all assay validity requirements and criteria.A retrospective analysis of customer data from august 10, 2022 - june 07, 2023, identified that m2000sp sn 12001 experienced the most error code (ecs) among all other m2000sp's utilized by the customer.Additionally, when comparing all hiv-1 amp kit lots utilized by the customer, lots 529905 and 531516 showed a higher total percentage of ecs.The customer stated the main issue is with amp kit lot 531516.Error code 4442 was the most prevalent among the instruments, indicating a potential sample preparation operation error that occurs when an insufficient amount of (internal control) ic is added to the lysis buffer or a potential sample preparation instrument error caused by reagent carryover, liquid handling errors, no liquid detected, sample-specific error (inhibition), or insufficient or incorrect assay reagent.Refer to the m2000rt operations manual, v8.1 (list 09k25-009) version 200680-108 - october 2016, for ecs 4442, 4450, and 4457.Upon comparing the internal control performance, the mean ic of all data across all instruments at customer site combined per lot shows that amp kit lot 531516 has a higher mean ic value when compared to all other hiv-1 amp kit lots utilized by the customer.The reported errors and quantitation issues due to temperature stress during shipment cannot be ruled out.Quality data review: device history record / batch record review: the device history records (dhr) review for abbott realtime hiv-1 amplification reagent kit (list 02g31-010) lots 531516 and 529905 and the components was performed.Review did not identify any issues which could result in the reported complaint.No issues were found during quality control (qc) testing.The qc amp kit masterlot testing met all acceptance and validity specification criteria.Capa / non-conformance review: a capa review was performed to identify any records that were potentially related to the reported complaint for abbott realtime hiv-1 amplification reagent kit (list 02g31-010) lot 531516 and 529905 and its components.This capa review did not identify any existing internal issues or nonconformances related to the reported complaint for abbott realtime hiv-1 amplification reagent kit (list 02g31-010) lot 531516, 529905 or its components.Complaint history review: a complaint history review was performed to identify any complaints related to the reported issue for the abbott realtime hiv-1 amplification reagent (list 02g31-010) lot 529905.A product deficiency was not identified by this review.The complaint history review identified four (4) additional complaints related to the reported complaint for the abbott realtime hiv-1 amplification reagent kit (part 02g31-010) lot 531516.No related complaints were identified for abbott realtime hiv-1 amplification reagent kit (part 02g31-010) lot 529905.Complaint trending was reviewed for this issue across all lots of list number 02g31; a trend was not identified in this review.Labeling review: the customer reported error codes (ecs) 4442, 4450, and 4457.The m2000rt operations manual, v8.1 (list 09k25-009) version 200680-108 - october 2016, was reviewed for ecs 4442, 4450, and 4457.Section 10 (troubleshooting and diagnostics), pages 42, 45, and 48 provides the definition, probable causes, and corrective actions for the reported error codes.The customer noted that there has been a previous temperature excursion event related to incorrect data logger positioning during delivery.A potential temperature excursion during transport could be an underlying factor impacting results.Three attempts have been made to gather temperature logs from cold chain and distributor sites.Abbott has not received any relevant data for the specified time in the complaint.Stability studies performed during development of the assay to establish product handling requirements and conditions based off transport and temperature extremes.The intended storage conditions are documented in abbott realtime hiv-1 package insert, (51-608282/r10).Based on the investigation elements, a product deficiency could not be identified by this review.

• Brand Name: ABBOTT REALTIME HIV-1
• Type of Device: TEST, HIV DETECTION
• Manufacturer (Section D): ABBOTT MOLECULAR, INC.; 1300 e. touhy ave.; des plaines IL
• Manufacturer (Section G): ABBOTT MOLECULAR, INC.; 1300 e. touhy ave.; des plaines IL 60016 3315
• Manufacturer Contact: albert chianello ; 1300 e. touhy ave.; des plaines, IL 60016-3315 ; 2242064064
• MDR Report Key: 17241552
• MDR Text Key: 318279494
• Report Number: 3005248192-2023-00193
• Device Sequence Number: 1
• Product Code: MZF
• Combination Product (y/n): N
• Reporter Country Code: HA
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Company Representative
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date: 08/02/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/30/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Expiration Date: 06/30/2023
• Device Catalogue Number: 02G31-010
• Device Lot Number: 529905
• Was Device Available for Evaluation?: Yes
• Date Manufacturer Received: 07/06/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 05/16/2022
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1