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

Catalog Number	05171385190
Medical Device Problem Code	Low Test Results (2458)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/23/2026
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The analyzer's serial number is (b)(6).The calibration and qc were acceptable.However, no qc data was provided from 01-mar-2026.It was noted that the sample's (sample 1) gel layer was poorly separated and contaminated with erythrocytes.The field service representative performed visual inspections and checks.He found that the solenoid valve for the sample syringes was rusted.He cleaned the solenoid valves for all of the syringes and replaced one of the valves.The investigation is ongoing.
Event or Problem Description
There was an allegation of questionable total protein gen.2 results for 2 patient samples on a cobas 8000 c702 module.Sample 1: the initial result was 0.2 g/dl, and the repeated result was 6.8 g/dl.The sample was repeated because the initial result didn't match the patient's clinical history.Sample 2: on (b)(6) 2026, the initial result was 0.4 g/dl, and the repeated result was 7.5 g/dl.
Additional Manufacturer Narrative
Additional questionable results were provided for total protein for one additional patient.Sample 3's initial total protein result on 01-mar-2026 was 0.0 g/dl.The repeat result on another analyzer was 7.03 g/dl.The alarm trace showed "abnormal aspiration" alarms.The field service representative performed multiple checks and tests with acceptable results.The investigation did not identify a product problem.The investigation determined the issue was consistent with pre-analytical handling issues.

• 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: 24628284
• Report Number: 1823260-2026-00977
• Device Sequence Number: 9068143
• Product Code: CEK
• UDI-Device Identifier: 04015630925100
• UDI-Public: 04015630925100
• Combination Product (Y/N): N
• Initial Reporter Country: EG
• 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): 04/20/2026

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: 05171385190
• Device Lot Number: 89894601
• 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: 02/23/2026
• Supplement Date Received by Manufacturer: 03/26/2026
• Initial Report FDA Received Date: 03/18/2026
• Supplement Report FDA Received Date: 04/20/2026
• 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