MAUDE Adverse Event Report: ROCHE DIAGNOSTICS cobas pro integrated solutions; Analyzer, chemistry (photometric, discrete), for clinical use

Catalog Number	09502971001
Medical Device Problem Code	High Test Results (2457)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/05/2026
Type of Reportable Event	Malfunction
Event or Problem Description
There was an allegation of questionable creatinine plus ver.2 results for 4 patient samples on a cobas c 703 analytical unit.Sample 1: the initial result was 5.08 mg/dl, and the repeated result was 0.64 mg/dl.Sample 2: on (b)(6) 2026, the initial result was 5.77 mg/dl, and the repeated result was 0.35 mg/dl.Sample 3 on (b)(6) 2026, the initial result was 4.68 mg/dl, and the repeated result was 1.18 mg/dl.Sample 4 on (b)(6) 2026, the initial result was 4.53 mg/dl, and the repeated result was 0.97 mg/dl.
Additional Manufacturer Narrative
E1 initial reporter establishment name: (b)(6).The analyzer's serial number is (b)(6).The investigation is ongoing.

• Brand Name: cobas pro integrated solutions
• Common Device Name: Analyzer, chemistry (photometric, discrete), for clinical use
• 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--045
• MDR Report Key: 25690822
• Report Number: 1823260-2026-02666
• Device Sequence Number: 18593017
• Product Code: JFY
• UDI-Device Identifier: 07613336200544
• UDI-Public: 07613336200544
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K024098
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• 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): 09/09/2026

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: 09502971001
• Device Lot Number: 93730901
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 06/08/2026
• Supplement Date Received by Manufacturer: 08/14/2026
• Initial Report FDA Received Date: 07/02/2026
• Supplement Report FDA Received Date: 09/09/2026
• 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
• Usage of Device: N
• Patient Sequence Number: 1
• Patient Sex: Unknown