MAUDE Adverse Event Report: ROCHE MOLECULAR SYSTEMS, INC. - BRANCHBURG COBAS® HIV-1 (192T); HUMAN IMMUNODEFICIENCY VIRUS (HIV) VIRAL LOAD MONITORING TEST

Catalog Number 09040803190

Device Problems False Positive Result (1227); High Test Results (2457)

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

Event Date 11/01/2023

Event Type  malfunction  

Manufacturer Narrative

The customer provided one cobas 6800 serial number as (b)(6).The investigation is ongoing.

Event Description

A customer alleged false positive hiv-1 results from several cobas 6800 analyzers and 8800 analyzers at the customer site.The patients are tested for monitoring purposes and are regularly negative.Allegedly, many of these patients return for testing following a previous positive result and later test negative again.Each test result was obtained from a fresh blood draw with no changes in treatment.The patient sample ids have been requested but have not been provided, therefore the specific patient data for each patient can not be determined at this time.

Manufacturer Narrative

Review of the provided data did not reveal any issues.An internal investigation into this allegation was performed and the conclusion was that the reagents have had no deviations during manufacturing and meet the specifications set for release.No trend was identified.No product problem was identified.The issue is likely related to pre-analytical handling.Lot-to-lot variability can also be a contributing factor.

• Brand Name: COBAS® HIV-1 (192T)
• Type of Device: HUMAN IMMUNODEFICIENCY VIRUS (HIV) VIRAL LOAD MONITORING TEST
• Manufacturer (Section D): ROCHE MOLECULAR SYSTEMS, INC. - BRANCHBURG; 1080 us highway 202 south; branchburg NJ 08876
• Manufacturer (Section G): ROCHE MOLECULAR SYSTEMS, INC. - BRANCHBURG; 1080 us highway 202 south; branchburg NJ 08876
• Manufacturer Contact: timothy blair ; 1080 us hwy 202 s; branchburg, NJ 08876 ; 9253534412
• MDR Report Key: 18870589
• MDR Text Key: 337744830
• Report Number: 2243471-2024-00718
• Device Sequence Number: 1
• Product Code: QUM
• UDI-Device Identifier: 00875197006407
• UDI-Public: 00875197006407
• Combination Product (y/n): Y
• Reporter Country Code: US
• PMA/PMN Number: BP150262/56
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 05/16/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 08/31/2024
• Device Catalogue Number: 09040803190
• Device Lot Number: K00224, K00517
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 02/09/2024
• Initial Date FDA Received: 03/08/2024
• Supplement Dates Manufacturer Received: 05/07/2024
• Supplement Dates FDA Received: 05/16/2024
• Was Device Evaluated by Manufacturer?: Yes
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1