MAUDE Adverse Event Report: ROCHE MOLECULAR SYSTEMS, INC. - BRANCHBURG COBAS® HIV-1/HIV-2 QUALITATIVE (192T); LAB-BASED HIV NAT DIAGNOSTIC AND/OR SUPPLEMENTAL TEST

Catalog Number	09040528190
Medical Device Problem Code	False Positive Result (1227)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/31/2026
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The cobas 5800 serial number was (b)(6).The investigation indicated no product-related issues were identified.The root cause is due to differences in technology.Confirmatory testing detects antibiodies against hiv-1 and hiv-2, as well as some viral antigens.Because it relies on the body's immune response, it takes longer to become positive, typically 3 to 8 weeks (or sometimes longer) after exposure.
Event or Problem Description
There was an allegation of discrepant cobas® hiv-1/hiv-2 qualitative (192t) results from the cobas 5800 analyzer for a single patient.On (b)(6) 2026, the initial sample was generated hiv-1 reactive (38.9), hiv-2 non-reactive results.Repeat on (b)(6) 2026 generated hiv-1 reactive (38.21), hiv-2 non-reactive results.The elecsys hiv combi generated a positive result (3,63 - 3,68 ¿ 3,73 s/co).The bio-rad geenius hiv 1/2 supplemental assay generated a negative result.Serology was negative.

• Brand Name: COBAS® HIV-1/HIV-2 QUALITATIVE (192T)
• Common Device Name: LAB-BASED HIV NAT DIAGNOSTIC AND/OR SUPPLEMENTAL 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: 25373029
• Report Number: 2243471-2026-02175
• Device Sequence Number: 21129132
• Product Code: QST
• UDI-Device Identifier: 00875197006384
• UDI-Public: 00875197006384
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• PMA/510(K) Number: BP190360/10
• 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): 06/03/2026

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: 08/31/2026
• Device Catalogue Number: 09040528190
• Device Lot Number: M25538
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 05/06/2026
• Initial Report FDA Received Date: 06/03/2026
• 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