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	Misfocusing (1401)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/20/2025
Type of Reportable Event	Malfunction
Event or Problem Description
There was an allegation of a misreading of a sample barcode when using the hamilton star compl.With accessories pooler.It was observed that the sample id (b)(6) was incorrectly read as (b)(6) during the pp96 repeat run.The same sample was correctly read during the original pp96 run.The sample was read multiple times using the hamilton cegd20122-h8 associated handheld scanner sick idm 140-21p06 (b)(6).The sample was predominantly read incorrectly.For comparison, the sample was also read with a department-internal handheld scanner, which consistently read the sample correctly.
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.
Additional Manufacturer Narrative
The investigation did not identify a product issue.The barcode was retained and has been investigated.The root cause is a barcode that has insufficient quality.The barcode resolution does not match the resolution of the barcode printer.

• 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: 22283387
• Report Number: 2243471-2025-01878
• Device Sequence Number: 15672347
• Product Code: JQW
• UDI-Device Identifier: 07630032600010
• UDI-Public: 07630032600010
• Combination Product (Y/N): N
• Initial Reporter Country: AU
• 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: Health Professional
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 08/15/2025

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 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: 05/22/2025
• Supplement Date Received by Manufacturer: 07/31/2025
• Initial Report FDA Received Date: 06/18/2025
• Supplement Report FDA Received Date: 08/15/2025
• 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