MAUDE Adverse Event Report: ROCHE MOLECULAR SYSTEMS, INC. - BRANCHBURG STAR COMPL. WITH ACCESSORIES; STATION, PIPETTING AND DILUTING, FOR CLINICAL USE

Catalog Number	04640535001
Medical Device Problem Code	Computer Software Problem (1112)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/09/2025
Type of Reportable Event	Malfunction
Event or Problem Description
There was an allegation of sample id mismatches when using the hamilton star compl.With accessories pooler.The customer reported that two of their poolers intermittently fail to recognize the correct number of sample pools, leading to sample ids being assigned to the wrong tubes.On pooler serial number (b)(6), initially, a batch of (b)(4) samples was loaded, expected to form 32 pools, but only (b)(4) pools were recognized.A similar issue occurred later, where only (b)(4) samples were recognized instead of 24.Additionally, the second pooler, serial number (b)(6), exhibited the same behavior.The customer rebooted the pooler and pc, which resolved the issue temporarily.No erroneous results were reported as the sample mismatches were resolved after reloading.
Additional Manufacturer Narrative
The hamilton star compl.With accessories is an instrument used with the cobas® 6800/8800 systems for automated pipetting and pooling of aliquots of multiple primary samples into one pooled sample.Investigation is ongoing.

• Brand Name: STAR COMPL. WITH ACCESSORIES
• Common Device Name: STATION, PIPETTING AND DILUTING, FOR CLINICAL USE
• Manufacturer (Section D): ROCHE MOLECULAR SYSTEMS, INC. - BRANCHBURG; 1080 us highway 202 south; branchburg NJ 08876
• Manufacturer (Section G): HAMILTON BONADUZ AG; via crusch 8; bonaduz 7402 ; SZ 7402
• Manufacturer Contact: natalie catton ; 9115 hague road; indianapolis, IN 46250 ; 9253534412
• MDR Report Key: 24650366
• Report Number: 2243471-2026-01016
• Device Sequence Number: 9894921
• Product Code: JQW
• UDI-Device Identifier: 07630032600010
• UDI-Public: 07630032600010
• Combination Product (Y/N): N
• Initial Reporter Country: UK
• PMA/510(K) Number: EXEMPT
• 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,Followup
• Report Date (Section B): 05/27/2026

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 Catalogue Number: 04640535001
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 12/17/2025
• Supplement Date Received by Manufacturer: 05/07/2026
• Initial Report FDA Received Date: 03/20/2026
• Supplement Report FDA Received Date: 05/27/2026
• 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