MAUDE Adverse Event Report: ROCHE DIAGNOSTICS COBAS PURE SAMPLE SUPPLY UNIT

Catalog Number	09793178001
Medical Device Problem Code	High Test Results (2457)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/15/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The cobas pure serial number was (b)(6).
Event or Problem Description
The initial reporter noticed qc for bilt3 bilirubin total gen.3 (bilt3) trending higher on their cobas pure sample supply unit.The customer replaced the reagent pack and repeated 6-8 patient samples.A discrepant high bilt3 result was provided for 1 patient sample.The initial result was 1.9 mg/dl.The repeat result was 0.2 mg/dl.The repeat result was believed to be correct.
Additional Manufacturer Narrative
Section d, device identification, was updated.Relevant fields of sections d and g were updated.The bilt3 reagent lot number was 858175 with an expiration date of 31-aug-2026.The field service engineer (fse) removed the reagent pack and registered a new reagent pack with the same lot number.Qc has since been stable.Since only one cassette was affected, a general issue with reagent lot 858175 was excluded.The water pump assembly was replaced as it was making noise.The sample probe was replaced and adjusted as a preventive measure.All mechanical checks passed.The investigation determined that the service actions resolved the issue.

• Brand Name: COBAS PURE SAMPLE SUPPLY UNIT
• Common Device Name: SAMPLE SUPPLY UNIT
• Manufacturer (Section D): ROCHE DIAGNOSTICS; 9115 hague road; indianapolis IN 46250 0457
• Manufacturer (Section G): HITACHI HIGH TECH CORP.; 882 ichige hitachinaka; ibaraki 312-8 504; JA 312-8504
• Manufacturer Contact: natalie catton ; 9115 hague road; indianapolis, IN 46250-0457
• MDR Report Key: 23769332
• Report Number: 1823260-2025-05034
• Device Sequence Number: 9667523
• Product Code: JJE
• UDI-Device Identifier: 07613336220146
• UDI-Public: 07613336220146
• Combination Product (Y/N): N
• Initial Reporter State: UT
• Initial Reporter Country: US
• PMA/510(K) Number: K220134
• 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,Followup
• Report Date (Section B): 01/23/2026

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 Expiration Date: 08/31/2026
• Device Catalogue Number: 09793178001
• Device Lot Number: 858175
• 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: 11/19/2025
• Supplement Date Received by Manufacturer: 01/08/2026
• Initial Report FDA Received Date: 12/10/2025
• Supplement Report FDA Received Date: 01/23/2026
• 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 Age: 75 YR
• Patient Sex: Female