MAUDE Adverse Event Report: ROCHE DIAGNOSTICS TOTAL PROTEIN GEN.2; BIURET TOTAL PROTEIN

Catalog Number	08058652190
Medical Device Problem Codes	Low Test Results (2458); Non Reproducible Results (4029)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/21/2025
Type of Reportable Event	Malfunction
Event or Problem Description
There was an allegation of questionable total protein gen.2 results for 1 patient sample on a cobas c 703 analytical unit.The initial result was 0.119 g/dl.The repeated result was 7.81 g/dl.The repeated result matched the patient's clinical history.
Additional Manufacturer Narrative
The analyzer's serial number is (b)(6).The calibration and qc were acceptable.The alarm trace showed several "abnormal aspiration alarms".A hardware performance check showed that rotor a was out of specification.The investigation is ongoing.
Additional Manufacturer Narrative
The investigation determined that the root cause was consistent with a hardware issue causing the triglycerides for rotor a to be out of specification.The investigation did not identify a specific cause of the event.

• Brand Name: TOTAL PROTEIN GEN.2
• Common Device Name: BIURET TOTAL PROTEIN
• Manufacturer (Section D): ROCHE DIAGNOSTICS; 9115 hague road; indianapolis IN 46250 0457
• 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
• MDR Report Key: 22017820
• Report Number: 1823260-2025-01481
• Device Sequence Number: 15805556
• Product Code: CEK
• UDI-Device Identifier: 07613336121528
• UDI-Public: 07613336121528
• Combination Product (Y/N): N
• Initial Reporter Country: CI
• PMA/510(K) Number: K951595
• 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): 07/09/2025

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: 08058652190
• Device Lot Number: 838819
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 04/21/2025
• Supplement Date Received by Manufacturer: 06/13/2025
• Initial Report FDA Received Date: 05/14/2025
• Supplement Report FDA Received Date: 07/09/2025
• 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