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	01/21/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The c303 analyzer serial number was (b)(6).
Event or Problem Description
The initial reporter alleged a stop error occurred on a cobas c 303 analytical unit.Reportedly, a specimen in process stopped processing and did not finish testing but results were produced and released.The customer noted flags on many of the results and repeated the sample.After repeat testing, discrepant results were identified for total protein gen.2 (tp2).The initial result was 6.36 g/dl.The repeat result was 7.97 g/dl.The repeat result was believed to be correct.
Additional Manufacturer Narrative
The field service engineer (fse) performed precision testing with qc material and the results were within specification.The last full calibration was performed on (b)(6) 2024 and was acceptable.Qc was acceptable.The sample was spun down for 8 minutes at 4780 revolutions per minute (rpm).This spin time may be shorter than recommended and the spin speed may be faster than recommended.Abnormal aspiration (sample pipetter) and sample short errors were observed in the alarm trace data.These are indicators of possible poor sample quality.For the allegation of the stop error contributing to the discrepant results: based on a review of the instrument logs, the discrepant total protein result was not yet pipetted at the time of the alarm and the request was canceled after the alarm was generated.The discrepant low result was not due to the stop error.The customer has had no further issues since the service visit.The investigation did not identify a product problem.The cause of the event could not be determined.

• 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: amy nelson ; 9115 hague road; indianapolis, IN 46250
• MDR Report Key: 21410584
• Report Number: 1823260-2025-00478
• Device Sequence Number: 9311988
• Product Code: CEK
• UDI-Device Identifier: 07613336121528
• UDI-Public: 07613336121528
• Combination Product (Y/N): N
• Initial Reporter State: TN
• Initial Reporter Country: US
• 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: Health Professional,User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 03/07/2025

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 Expiration Date: 08/31/2025
• Device Catalogue Number: 08058652190
• Device Lot Number: 80429201
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 01/23/2025
• Supplement Date Received by Manufacturer: 02/20/2025
• Initial Report FDA Received Date: 02/19/2025
• Supplement Report FDA Received Date: 03/07/2025
• 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 Age: 71 YR
• Patient Sex: Male