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

Catalog Number	03183734190
Medical Device Problem Code	Non Reproducible Results (4029)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/27/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Calibration and controls were acceptable.The field application specialist verified that calibration and controls were acceptable.Precision studies were performed and recovered within specifications.A comparison experiment was performed using mixed and centrifuged samples; no observable difference was noted.The investigation is ongoing.
Event or Problem Description
The initial reporter stated they received discrepant results for four patient samples tested with total protein/total protein stat on a cobas 6000 c501 module.The samples were repeated the next day as the low values did not match the previous results of the patients.The first sample initially resulted in a total protein value of 7.21 g/dl.The sample was repeated, resulting in values of 8.65 g/dl, 8.65 g/dl, and 8.89 g/dl.The second sample initially resulted in total protein values of 3.77 g/dl with a data flag and 3.85 g/dl.The sample was repeated, resulting in values of 6.49 g/dl and 6.32 g/dl.The third sample initially resulted in total protein values of 3.07 g/dl with a data flag, 3.07 g/dl, and 3.13 g/dl.The sample was repeated, resulting in values of 7.37 g/dl and 7.09 g/dl.The fourth sample initially resulted in total protein values of 1.78 g/dl with a data flag and 1.91 g/dl.The sample was repeated, resulting in values of 6.34 g/dl, 6.57 g/dl, and 6.40 g/dl.The patients' results were amended.
Additional Manufacturer Narrative
The c501 module serial number was (b)(6).The field service engineer (fse) checked multiple parts of the instrument and no issues were identified.Precision checks were within specification.An abnormal probe-sucking alarm was observed on the day of the event.The patient samples in question were pipetted before and after this alarm.No issues were observed during a review of the reaction monitor data.The hardware performance check (hpc) was within specification.Based on the information provided, the investigation determined the event was consistent with a pre-analytical handling issue.

• 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: 20267674
• Report Number: 1823260-2024-02721
• Device Sequence Number: 7212354
• Product Code: CEK
• UDI-Device Identifier: 04015630918928
• UDI-Public: 04015630918928
• Combination Product (Y/N): Y
• Initial Reporter Country: SN
• 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): 10/10/2024

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: 08/28/2024
• Supplement Date Received by Manufacturer: 10/08/2024
• Initial Report FDA Received Date: 09/20/2024
• Supplement Report FDA Received Date: 10/10/2024
• 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 Sex: Unknown