MAUDE Adverse Event Report: ROCHE DIAGNOSTICS TPUC3; TURBIDIMETRIC, TOTAL PROTEIN

Model Number	TPUC G3
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	04/30/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The customer did not provide any additional information for the investigation.Based on the information provided, the issue is consistent with a high protein concentration in the patient¿s sample.Per product labeling: "urine, csf and control samples with a protein concentration above 7000 mg/l must not be measured with tpuc3 as this may clog the instrument lines.".The investigation did not identify a product problem.
Event or Problem Description
The initial reporter stated they received discrepant results for one patient sample tested with the tpuc3 (total protein urine/csf gen.3) assay on a cobas 6000 c 501 module, serial number (b)(6).The sample initially resulted in a tpuc3 value of 0.7 g/l.The result was reported outside of the laboratory and questioned by the physician.The sample was repeated, resulting in a tpuc3 value of 14.8 g/l.The reporter also mentioned that urine test strips show a high protein concentration.

• Brand Name: TPUC3
• Common Device Name: TURBIDIMETRIC, TOTAL PROTEIN
• Manufacturer (Section D): ROCHE DIAGNOSTICS; 9115 hague road; indianapolis IN 46250 0457
• Manufacturer (Section G): ROCHE DIAGNOSTICS GMBH; sandhoferstrasse 116; na; mannheim (baden-wurttemberg) 68305 ; GM 68305
• Manufacturer Contact: amy nelson ; 9115 hague road; na; indianapolis, IN 46250 ; 3174767531
• MDR Report Key: 17030348
• Report Number: 1823260-2023-01791
• Device Sequence Number: 12505867
• Product Code: JGQ
• UDI-Device Identifier: 04015630919536
• UDI-Public: 04015630919536
• Combination Product (Y/N): N
• Initial Reporter Country: BE
• PMA/510(K) Number: K141925
• 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
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 05/31/2023

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 Model Number: TPUC G3
• Device Catalogue Number: 03333825190
• Device Lot Number: ASKU
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/04/2023
• Initial Report FDA Received Date: 05/31/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• 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