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	High Test Results (2457)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/21/2025
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 undetermined but appears sample-specific.Possible explanations for the discrepancy include: the initial sample was collected during hiv's "window period," when tests may not detect infection.An lod sample, when recollected showed up with negative results due to wavering results.Contamination of the initial sample.A sample mix-up.
Event or Problem Description
There was an allegation of discrepant cobas® hiv-1 (192t) results from the cobas 5800 analyzer for a single patient.On (b)(6) 2025, the initial sample was generated a positive hiv result 4 times on the cobas 5800 with the following results: -titer 21 cp/ml (logtiter 1.33) -< titer min.-titer 29 cp/ml (logtiter 1.46).-titer 39 cp/ml (logtiter 1.56)".Serology for the initial sample was negative.The sample was recollected and generated "target not detected" results for hiv with both the cobas® hiv-1 (192t) on the c6800 test and the serology test.

• 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: 22850682
• Report Number: 2243471-2025-02560
• Device Sequence Number: 8458142
• Product Code: MZF
• UDI-Device Identifier: 00875197006407
• UDI-Public: 00875197006407
• Combination Product (Y/N): N
• Initial Reporter Country: SA
• 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): 08/20/2025

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: 12/31/2025
• Device Catalogue Number: 09040803190
• Device Lot Number: K25811
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 07/21/2025
• Initial Report FDA Received Date: 08/20/2025
• 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
• Concomitant Medical Products and Therapy/Usage Dates: ASPIRIN (ASPIR-LOW) 81 MG.; ATORVASTATIN (LIPITOR) 40 MG.; DICLOFENAC (VOLTAREN) 1 % TOPICAL GEL.; EZETIMIBE (EZETROL) 10 MG.; OMEPRAZOLE (RISEK) 20 MG.; R, CLOPIDOGREL -BISULFATE (PLAVIX) 75 MG- BISOPROLO.
• Patient Sex: Unknown