MAUDE Adverse Event Report: ROCHE MOLECULAR SYSTEMS, INC. - BRANCHBURG COBAS AMPLIPREP/COBAS TAQMAN HIV-1 TEST, V2.0; TEST, HIV DETECTION

Catalog Number	05212308190
Medical Device Problem Codes	Incorrect, Inadequate or Imprecise Result or Readings (1535); Output Problem (3005)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/26/2020
Type of Reportable Event	Malfunction
Event or Problem Description
The initial reporter alleged discrepant results with the cobas ampliprep/cobas taqman hiv-1 test, v2.0 for two patient samples on a cobas ampliprep analyzer.Sample 1: the initial result was 425 cp/ml.The repeat result was <2.00e+01cp/ml.Sample 2: the initial result was 159 cp/ml.The repeat result was target not detected.It is unknown if the samples were from separate or the same draw.
Additional Manufacturer Narrative
The serial number of the analyzer was (b)(6).A review of the control data from the alleged runs confirmed that the controls were valid and comparable to the quality control release data for the implicated lot, with no significant deviations observed.The observed discrepant results could potentially be attributed to sample-specific factors, such as low-level viremia or the presence of proviral dna due to buffy coat transfer during sample handling.Other potential contributing factors include laboratory contamination, sample handling or storage conditions, or inherent assay-to-assay and run-to-run variability.No reagent-related issues were identified.The investigation did not identify a product issue, and no trend was observed for the implicated lot.The device remains in operation at the customer site.

• Brand Name: COBAS AMPLIPREP/COBAS TAQMAN HIV-1 TEST, V2.0
• Common Device Name: TEST, HIV DETECTION
• 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: 23057780
• Report Number: 2243471-2025-02886
• Device Sequence Number: 15607773
• Product Code: MZF
• UDI-Device Identifier: 00875197003024
• UDI-Public: 00875197003024
• Combination Product (Y/N): N
• Initial Reporter State: CO
• Initial Reporter Country: US
• PMA/510(K) Number: BP050069-20
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional,User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 09/15/2025

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: 12/31/2020
• Device Catalogue Number: 05212308190
• Device Lot Number: F16775
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 04/10/2020
• Initial Report FDA Received Date: 09/15/2025
• 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