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

Catalog Number	08058652190
Medical Device Problem Code	Non Reproducible Results (4029)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/21/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The analyzer serial number is (b)(6).The calibration and qc recovery data provided was acceptable.The field service engineer (fse) replace a bent and dirty sample probe, adjusted the sample and reagent probes, adjusted the gear pump pressure, replaced the cuvettes and lamp, adjusted the blank cell water distribution in the cuvettes, and performed a hardware check and qc successfully.The investigation is ongoing.
Event or Problem Description
There was an allegation of questionable tp2 total protein gen.2 results for 1 patient sample on a cobas pro c 503 analytical unit.The initial tp2 result was 6 g/l.The customer questioned the result as it did not match the patient's previous result and was prompted to repeat the sample.The repeat result was 54 g/l.No questionable results were reported outside of the laboratory.
Additional Manufacturer Narrative
The investigation did not identify a product problem.The root cause of the event was found to be consistent with pre-analytical sample handling issues.

• 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; sandhofer strasse 116; mannheim (baden-wurttemberg) 68305 ; GM 68305
• Manufacturer Contact: amy nelson ; 9115 hague road; indianapolis, IN 46250
• MDR Report Key: 18606696
• Report Number: 1823260-2024-00259
• Device Sequence Number: 9033899
• Product Code: CEK
• UDI-Device Identifier: 07613336121528
• UDI-Public: 07613336121528
• Combination Product (Y/N): Y
• Initial Reporter Country: FR
• 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): 02/26/2024

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 Expiration Date: 02/28/2025
• Device Catalogue Number: 08058652190
• Device Lot Number: 76240601
• 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: 01/02/2024
• Supplement Date Received by Manufacturer: 02/06/2024
• Initial Report FDA Received Date: 01/30/2024
• Supplement Report FDA Received Date: 02/26/2024
• 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