MAUDE Adverse Event Report: ROCHE MOLECULAR SYSTEMS, INC. - BRANCHBURG COBAS® NHP NEGATIVE CONTROL KIT; ASSAY,HYBRIDIZATION &/OR NUCLEIC ACID AMPLIFICATION FOR DETECT OF HEP C RNA&HCV

Catalog Number	07002220190
Medical Device Problem Codes	False Positive Result (1227); 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	08/06/2020
Type of Reportable Event	Malfunction
Event or Problem Description
The initial reporter alleged unexpected reactive results for hiv in both sample pools and negative controls when using the cobas® 6800/8800 mpx assay and kit cobas 6800/8800 nhp neg rmc ivd on the cobas 8800 analyzer.Two sample pools were reported as reactive for hiv.The first pool, tested on instrument 5149 at 06:18, had a cycle threshold (ct) value of 37.59.The second pool, also tested on instrument 5149 at 08:36, had the same ct value of 37.59.Both pools were subsequently resolved on instrument 5100.For the first pool, all resolution testing was non-reactive.For the second pool, two batches were tested: batch 12606 samples were all non-reactive, and batch 12608, repeated on instrument 5149, was also non-reactive.Final resolution results for both pools were non-reactive, consistent with negative serology results for all samples.The final results for all samples were non-reactive.
Additional Manufacturer Narrative
The reported event occurred on a cobas 8800 analyzer with serial number (b)(6).The investigation determined that the kit cobas 6800/8800 nhp neg rmc ivd assay performed within specifications.A review of the hiv target growth curves for all reactive samples and negative controls indicated robust but late amplification, while growth curves for target positive controls and internal controls were sigmoidal and robust, confirming proper assay performance.Potential causes for the unexpected reactive results in the negative controls include contamination, possibly due to deviations from optimal workflow during reagent handling, storage, or instrument use.Non-specific amplification was considered but deemed highly unlikely based on the growth curve characteristics.The investigation was limited by the unavailability of amplification-detection plates for further testing.No issues were identified in the batch trend analysis, product release, stability review, or internal non-conformance review.The device remains in operation at the customer site, and the final results for all samples and negative controls were non-reactive.

• Brand Name: COBAS® NHP NEGATIVE CONTROL KIT
• Common Device Name: ASSAY,HYBRIDIZATION &/OR NUCLEIC ACID AMPLIFICATION FOR DETECT OF HEP C RNA&HCV
• Manufacturer (Section D): ROCHE MOLECULAR SYSTEMS, INC. - BRANCHBURG; 1080 us highway 202 south; branchburg NJ 08876
• Manufacturer (Section G): ROCHE DIAGNOSTICS GMBH; sandhofer strasse 116; mannheim (baden-wurttemberg) 68305 ; GM 68305
• Manufacturer Contact: natalie catton ; 9115 hague road; indianapolis, IN 46250 ; 9253534412
• MDR Report Key: 23086578
• Report Number: 2243471-2025-03129
• Device Sequence Number: 10502089
• Product Code: QHO
• UDI-Device Identifier: 00875197005127
• UDI-Public: 00875197005127
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• PMA/510(K) Number: BL125699
• 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): 09/18/2025

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: 04/30/2021
• Device Catalogue Number: 07002220190
• Device Lot Number: G01748
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 08/06/2020
• Initial Report FDA Received Date: 09/18/2025
• 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