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

Catalog Number	09040803190
Medical Device Problem Code	Incorrect, Inadequate or Imprecise Result or Readings (1535)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/05/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The reported event occurred on a cobas 5800 analyzer (serial number: (b)(6)).The investigation determined that the cobas hiv-1/hiv-2 qualitative and quantitative assays performed within specifications.A review of the data indicated that the observed discrepancies were consistent with a sample at or near the limit of detection (lod) for the assays used.No errors, alarms, or anomalies were identified in the system's message logs, tadm curves, or pcr curves.The investigation was limited by the absence of problem reports and complete dataset availability.The root cause was attributed to sample-specific factors, with contamination as a potential contributing factor.No product issue was identified, and the investigation concluded that the system and assays were functioning as intended.
Event or Problem Description
The initial reporter alleged discrepant results using the kit cobas 58/68/8800 hiv 192t ivd on the cobas 5800 instrument.The allegation involved a sample tested with both the cobas hiv-1/hiv-2 qualitative assay and the cobas hiv-1 quantitative assay.On (b)(6) 2025, the qualitative assay generated a reactive result for hiv-1 with a cycle threshold (ct) value of 39.1.On (b)(6) 2025, the quantitative assay for the same sample returned a result of 'target not detected' (tnd).The sample was tested from a primary tube containing edta with separation gel.Between tests, the sample remained in the instrument and was not centrifuged.No serology results were available.The laboratory received simultaneous orders for both qualitative and quantitative tests.Due to the inconclusive results, a second sample was requested.No harm was alleged.

• Brand Name: COBAS® HIV-1 (192T)
• 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: 23098320
• Report Number: 2243471-2025-03240
• Device Sequence Number: 21168899
• Product Code: MZF
• UDI-Device Identifier: 00875197006407
• UDI-Public: 00875197006407
• Combination Product (Y/N): N
• Initial Reporter Country: PL
• 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): 09/19/2025

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: 02/28/2026
• Device Catalogue Number: 09040803190
• Device Lot Number: M03020
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 02/10/2025
• Initial Report FDA Received Date: 09/19/2025
• 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