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

Model Number	TPUC G3
Medical Device Problem Code	Non Reproducible Results (4029)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/25/2022
Type of Reportable Event	Malfunction
Event or Problem Description
The initial reporter received questionable tpuc3 total protein csf gen.3 results on a cobas 4000 c311 analyzer with serial number (b)(4).The initial csf tp result was 13.85 g/l.The high result prompted the customer to send the sample to another lab to repeat it.The repeat result from the other lab with the same reagent lot on a c8000 analyzer was 14 g/l.The second lab referred the sample to a third reference lab for electrophoresis and pandy sulfosalicylic acid qualitative testing and the results came back within normal range.The electrophoresis result matched the patient's clinical picture.The initial result was reported outside of the laboratory.The electrophoresis result was deemed correct.
Additional Manufacturer Narrative
Per product labeling, "urine, csf and control samples with a protein concentration above 7000 mg/l (700 mg/dl) may clog the instrument lines." the investigation is ongoing.
Additional Manufacturer Narrative
The patient had viral meningitis at the time of sample collection.The investigation did not identify a product problem.The cause of the event could not be determined.
Additional Manufacturer Narrative
The information in the previous supplemental report was incorrect.The correct information is: the investigation found that the issue is consistent with elevated protein concentration in the patient's sample.Per product labeling, "urine, csf and control samples with a protein concentration above 7000 mg/l (700 mg/dl) may clog the instrument lines.".

• 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: 15292741
• Report Number: 1823260-2022-02540
• Device Sequence Number: 7166799
• Product Code: JGQ
• UDI-Device Identifier: 04015630919536
• UDI-Public: 04015630919536
• Combination Product (Y/N): N
• Initial Reporter Country: AR
• 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,User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 10/24/2022

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: 03/31/2023
• Device Model Number: TPUC G3
• Device Catalogue Number: 03333825190
• Device Lot Number: 59944801
• 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: 07/28/2022
• Supplement Date Received by Manufacturer: 09/28/2022; 09/28/2022
• Initial Report FDA Received Date: 08/25/2022
• Supplement Report FDA Received Date: 10/21/2022; 10/24/2022
• 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