MAUDE Adverse Event Report: ROCHE DIAGNOSTICS TP2; BIURET (COLORIMETRIC), TOTAL PROTEIN

Catalog Number	04657586190
Medical Device Problem Codes	Incorrect, Inadequate or Imprecise Result or Readings (1535); Material Integrity Problem (2978)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/04/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The cobas c111 analyzer serial number was (b)(6).The investigation is ongoing.
Event or Problem Description
We received an allegation about discrepant results for 2 patients' samples tested with total protein 400t (tp2) assay on a cobas c111 analyzer.Sample 1 (patient 1): initial result: 5.9 mg/dl.Repeat result: 7.2 mg/dl (tested with a new reagent vial).The unit of measurement of mg/dl was requested to be verified but a clarification was not received yet.Sample 2 (patient 2): initial result: 6.0.Repeat result: 7.1 (tested with a new reagent vial).The unit of measurement was not provided.The physician questioned the initial results as they did not match the patient's clinical picture and requested the samples to be repeated.
Additional Manufacturer Narrative
No questionable results were reported outside the laboratory.The data was requested for investigation but it was not provided despite several reminders.The investigation did not identify a product problem.

• Brand Name: TP2
• 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: 20157505
• Report Number: 1823260-2024-02579
• Device Sequence Number: 8232514
• Product Code: CEK
• UDI-Device Identifier: 04015630922833
• UDI-Public: 04015630922833
• Combination Product (Y/N): Y
• Initial Reporter Country: JO
• PMA/510(K) Number: EXEMPT
• 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): 10/04/2024

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: 04657586190
• Device Lot Number: 770129
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 08/12/2024
• Supplement Date Received by Manufacturer: 09/29/2024
• Initial Report FDA Received Date: 09/06/2024
• Supplement Report FDA Received Date: 10/04/2024
• 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