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 Code	False Positive Result (1227)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/27/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The reported event occurred on a cobas 6800 analyzer (serial number: (b)(6).The investigation determined that the cobas mpx assay performed within specifications.A review of the data provided by the customer indicated that the hiv growth curves for the two samples exhibited late and minimal amplification, with cycle threshold (ct) values of 39.1 and 42.2.The positive control for hiv demonstrated robust and sigmoidal amplification, confirming proper assay performance.Based on the clinical context and the observed amplification patterns, the most likely cause of the discrepant results was identified as non-specific amplification.Contamination of the samples was considered less likely.The blood donations associated with the samples were discarded, and no harm or delay in treatment was reported.
Event or Problem Description
The initial reporter alleged unexpected reactive results for hiv when using the cobas mpx assay on the cobas 6800 instrument.The customer reported two samples that were initially reactive for hiv with cycle threshold (ct) values of 39.1 and 42.2.The hiv growth curve for both samples showed late and minimal amplification.Serology testing for both samples was non-reactive.The cobas mpx assay was repeated on the same samples, and the results were non-reactive.The samples were reported as reactive, and the blood donations were discarded.

• 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: 23094355
• Report Number: 2243471-2025-03166
• Device Sequence Number: 8686101
• Product Code: QHO
• UDI-Device Identifier: 00875197005127
• UDI-Public: 00875197005127
• Combination Product (Y/N): N
• Initial Reporter Country: TH
• 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): 09/19/2025

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: 07/31/2024
• Device Catalogue Number: 07002220190
• Device Lot Number: J29484
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 11/27/2023
• 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