MAUDE Adverse Event Report: ROCHE DIAGNOSTICS TPUC3; TOTAL PROTEIN

Catalog Number	05171954190
Medical Device Problem Code	Low Test Results (2458)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/13/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The serial number of the c 701 analyzer is (b)(6).The investigation is ongoing.
Event or Problem Description
The initial reporter stated they received a questionable result for one patient's urine sample tested with tpuc3 (total protein) on a cobas 8000 cobas c 701 module.The total protein result was deemed implausible based on the patient's history, condition, and measured microalbumin value.After further measurements, discrepancies in results also occurred for the albt2 tina-quant albumin gen.2 (microalbumin) assay.The customer noted that the sample appeared cloudy even after centrifugation.This medwatch will apply to the total protein assay.Please refer to the medwatch with a1.Patient identifier (b)(6) for information related to the microalbumin assay.The urine sample initially resulted in the following values: total protein= 1620 mg/l.Microalbumin = 3720 mg/l.The system photometer checks showed a high absorbance since (b)(6) 2023.An in-house technician at the customer site changed the heat cut filter on the analyzer.The photometer check was ok after changing the heat cut filter.Further repeats of the sample occurred on (b)(6) 2023 after the heat cut filter was changed.The customer noted the sample had been stored at 4 degrees celcius after initial testing.The sample was manually diluted 1:2 and repeated on (b)(6) 2023, resulting in the following values: total protein= 88.5 mg/l raw value and 177 mg/l when accounting for the dilution factor.Microalbumin = 651.8 mg/l raw value and 1303.6 mg/l when accounting for the dilution factor.The sample was repeated using a 1:50 automatic dilution on (b)(6) 2023, resulting in the following values: total protein= 159.0 mg/l.Microalbumin = 1354.1 mg/l.
Additional Manufacturer Narrative
On (b)(6) 2023, the patient had a urine total protein result of 976 mg/l and a urine albumin result of 821 mg/l.
Additional Manufacturer Narrative
The initial microalbumin value of 3720 mg/l was measured using decreased sample volume.The investigation could not identify a product problem.The cause of the event could not be determined.According to the provided patient medications, an interference is not expected.The issue is related to the patient sample.The sample was very turbid, even after centrifugation.Re-measurement of the sample was not possible as the customer did not store it at the required temperature.

• Brand Name: TPUC3
• Common Device Name: 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: 17977588
• Report Number: 1823260-2023-03382
• Device Sequence Number: 16770610
• Product Code: JGQ
• UDI-Device Identifier: 04015630925179
• UDI-Public: 04015630925179
• Combination Product (Y/N): Y
• Initial Reporter Country: GM
• PMA/510(K) Number: K071239
• 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): 11/21/2023

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 Expiration Date: 08/31/2024
• Device Catalogue Number: 05171954190
• Device Lot Number: 73046101
• 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: 09/26/2023
• Supplement Date Received by Manufacturer: 10/26/2023; 11/10/2023
• Initial Report FDA Received Date: 10/20/2023
• Supplement Report FDA Received Date: 11/17/2023; 11/21/2023
• 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
• Concomitant Medical Products and Therapy/Usage Dates: ALLOPURINOL; AMLODIPIN; JARDIANCE; L-THYROXIN; RAMIPRIL; TORASEMID
• Patient Sex: Unknown