MAUDE Adverse Event Report: ROCHE DIAGNOSTICS TOTAL PROTEIN GEN.2; BIURET TOTAL PROTEIN

Model Number	C503
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	03/20/2023
Type of Reportable Event	Malfunction
Event or Problem Description
We received an allegation of questionable results for 7 patient's sample tested with tp2 (total protein) assay on a cobas pro c503 analytical unit serial number (b)(4) compared to another cobas pro c503 analytical unit serial number (b)(4).On (b)(6) 2023 the customer initially ran the samples on cobas pro c503 analytical unit serial number 2176-06.The questionable results were reported outside of the laboratory.The physician questioned the results.The next day, the samples were repeated on a different cobas pro c503 analytical unit serial number 2169-06 and they got corrected.Sample 1: initial result: 3.5 g/dl.Repeat result: 6.84 g/dl.Sample 2: initial result: 4.8 g/dl.Repeat result: 7.21 g/dl.Sample 3: initial result: 3.6 g/dl.Repeat result: 7.31 g/dl.Sample 4: initial result: 0.6 g/dl.Repeat result: 7.65 g/dl.Sample 5: initial result: 3.6 g/dl.Repeat result: 7.3 g/dl.Sample 6: initial result: 3.9 g/dl.Repeat result: 6.71 g/dl.Sample 7: initial result: 0.2 g/dl.Repeat result: 7.56 g/dl.The tp2 reagent lot number was 693361.The expiration date was not provided.Qc and calibration were within the aceptable range.
Additional Manufacturer Narrative
The field service engineer found no hardware issues.The customer was concerned about the environmental conditions in the laboratory as the laboratory's humidity was 41.The unit of measurement of the humidity was not provided.The customer was also concerned receiving the samples with clots.The customer has a plan of action in place to address the laboratory's environmental concerns.Precision studies were performed and they were within specifications.The fse verified the system pulse adjustments, the fluidic volumes for probe and cell rinse units, the sodium levels for mixer and the downstream vacuum functunality through cell blank.The fse ran an instrument check and it was within specifications.Qc was performed and was acceptable.
Additional Manufacturer Narrative
During the investigation, the alarm trace showed abnormal sample aspiration and sample short alarms.The unit of measurement of the humidity was provided as %.Therefore, the laboratory's humidity was 41%.

• 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; sandhoferstrasse 116; na; mannheim (baden-wurttemberg) 68305 ; GM 68305
• Manufacturer Contact: amy nelson ; 9115 hague road; na; indianapolis, IN 46250 ; 3174767531
• MDR Report Key: 16742920
• Report Number: 1823260-2023-01262
• Device Sequence Number: 12333746
• Product Code: CEK
• UDI-Device Identifier: 07613336121528
• UDI-Public: 07613336121528
• Combination Product (Y/N): N
• 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): 05/30/2023
• 2 Devices were Involved in the Event: 1 2

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: 02/29/2024
• Device Model Number: C503
• Device Catalogue Number: 08058652190
• Device Lot Number: 69336101
• 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: 03/22/2023
• Supplement Date Received by Manufacturer: 05/03/2023
• Initial Report FDA Received Date: 04/14/2023
• Supplement Report FDA Received Date: 05/30/2023
• 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