MAUDE Adverse Event Report: ROCHE DIAGNOSTICS TOTAL PROTEIN/TOTAL PROTEIN STAT; BIURET (COLORIMETRIC), TOTAL PROTEIN

Catalog Number	03183734190
Medical Device Problem Code	Low Test Results (2458)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/29/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The instrument used was a cobas 8000 cobas c 502 module with serial number (b)(6).Further information about the patient's medical history and medication was requested but not yet provided.The investigation is ongoing.
Event or Problem Description
There was an allegation of questionable tp2 (total protein) assay results for a patient sample tested on a cobas 8000 cobas c 502 module that did not match the results of the albumin and iggam measurements of the same sample.It was alleged that the individual results of albumin, igm, and iga would suggest a higher concentration of total protein in total.The customer suspected an interference.The initial result was 34.6 g/l.The repeat result on (b)(6) 2024 was 35.2 g/l and on (b)(6) 2024 was 35.7 g/l.The total protein results were not reported outside of the laboraory.
Additional Manufacturer Narrative
The field service engineer found the tubing on the system was brittle.The investigation did not identify a product problem.The specific cause of the event could not be determined.

• Brand Name: TOTAL PROTEIN/TOTAL PROTEIN STAT
• Common Device Name: BIURET (COLORIMETRIC), 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: 18777660
• Report Number: 1823260-2024-00542
• Device Sequence Number: 4512501
• Product Code: CEK
• UDI-Device Identifier: 04015630918928
• UDI-Public: 04015630918928
• Combination Product (Y/N): Y
• Initial Reporter Country: WZ
• 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): 05/29/2024

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: 03183734190
• Device Lot Number: 771915
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 02/02/2024
• Supplement Date Received by Manufacturer: 05/29/2024
• Initial Report FDA Received Date: 02/26/2024
• Supplement Report FDA Received Date: 05/29/2024
• 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: 80 YR
• Patient Sex: Unknown