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

Catalog Number	09040803190
Medical Device Problem Code	Non Reproducible Results (4029)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/22/2024
Type of Reportable Event	Malfunction
Event or Problem Description
There was an allegation of discrepant cobas® hiv-1 results for one patient sample tested on a cobas 8800 analyzer.On (b)(6) 2024, the initial result was 82,000 cp/ml.This result was unexpected as the patient is usually around 134 cp/ml.On (b)(6) 2024, the same sample tube was repeated and the result was 13,600 cp/ml.Date unknown, a new sample was obtained from the patient and the result was according to the expected value.
Additional Manufacturer Narrative
The serial number of the analyzer was (b)(6).A batch trend was not identified for the alleged kit lot k00224.A holistic view of the reagents and the reagent kit does not indicate a product problem.Based on the available information, the exact root cause could not be determined.However, the discrepancy is consistent with a contamination of the primary tube as both tests were out of the same tube, with the lower titer being second after a freeze/thaw and potential time at room temperature/more handling.The customer also agreed that contamination is the most likely contributor as one of the samples in the run was at a very high titer (titer above range).The investigation determined that the differences observed are sample-specific.Inadvertent contamination is plausible.

• Brand Name: COBAS® HIV-1
• Common Device Name: 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: natalie catton ; 9115 hague road; indianapolis, IN 46250 ; 9253534412
• MDR Report Key: 22914127
• Report Number: 2243471-2025-02640
• Device Sequence Number: 15731023
• Product Code: MZF
• UDI-Device Identifier: 00875197006407
• UDI-Public: 00875197006407
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• PMA/510(K) Number: BP150262
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 08/28/2025

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
• Operator of Device: Health Professional
• Device Expiration Date: 08/31/2024
• Device Catalogue Number: 09040803190
• Device Lot Number: K00224
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 06/06/2024
• Initial Report FDA Received Date: 08/28/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Sex: Unknown