MAUDE Adverse Event Report: ROCHE DIAGNOSTICS TOTAL PROTEIN GEN.2; BIURET (COLORIMETRIC), TOTAL PROTEIN

Catalog Number	03183734190
Medical Device Problem Codes	Low Test Results (2458); No Apparent Adverse Event (3189)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/09/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The c501 module serial number was (b)(6).
Event or Problem Description
The initial reporter questioned results for multiple patient samples tested for total protein gen.2 (tp2) on a cobas 6000 c (501) module.Discrepant results were provided for 1 patient sample.The initial result was 0.7 g/dl.The repeat result from a different c501 module was 7.1 g/dl.The repeat result was believed to be correct.
Additional Manufacturer Narrative
The field service engineer (fse) found the customer had downloaded new h2o calibrator parameters but only recalibrated the primary reagent pack.The customer did not qc the standby reagent packs correctly.The standby reagent pack failed qc but the customer did not resolve the qc issue on that reagent pack.When the primary reagent pack ran out and changed to the standby reagent pack, patient results were low.After recalibrating the reagent pack causing the issue, the correct results were received.A precision check passed.The sample was spun down for 5 minutes at 3500 revolutions per minute (rpm).This spin time may be shorter than recommended.Abnormal probe sucking, abnormal sample aspiration, and sample short errors were observed on the alarm trace data.These are indicators of possible poor sample quality.The investigation determined the event was due to the customer's calibrator and qc handling.The issue was resolved by recalibrating the affected reagent pack.

• Brand Name: TOTAL PROTEIN GEN.2
• 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: 21526631
• Report Number: 1823260-2025-00634
• Device Sequence Number: 12856606
• Product Code: CEK
• UDI-Device Identifier: 04015630918928
• UDI-Public: 04015630918928
• Combination Product (Y/N): N
• Initial Reporter State: TN
• 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): 03/21/2025

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: 11/30/2025
• Device Catalogue Number: 03183734190
• Device Lot Number: 82266201
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 02/09/2025
• Supplement Date Received by Manufacturer: 03/17/2025
• Initial Report FDA Received Date: 03/05/2025
• Supplement Report FDA Received Date: 03/21/2025
• 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 Age: 55 YR
• Patient Sex: Male