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

Catalog Number	08058652190
Medical Device Problem Code	Output Problem (3005)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/16/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The tp2 expiration date was not provided.The albp reagent lot number and expiration date were not provided.The cobas pro c503 analytical unit serial number was (b)(6).The alarm trace showed abnormal aspiration alarms.The field service engineer (fse) visited the customer's site and found no issues with the analyzer.The fse replaced the sample probe.The customer had no further issues after the sample probe was replaced.The root cause was consistent with a pre-analytical issue.
Event or Problem Description
We received an allegation about discrepant results for 1 patient's sample tested with total protein gen.2 (tp2) assay and albumin bcp (albp) assay on a cobas pro c503 analyzer.This medwatch will apply to the tp2 assay.Please refer to the medwatch with a1.Patient identifier (b)(6) for information related to the albp assay.Tp2: initial result: 5.60 g/l.Repeat result: 75.3 g/l.Albp: initial result: 4.83 g/l.Repeat result: 42.4 g/l.The medical personnel questioned the results and the sample was then repeated.

• 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: 18305589
• Report Number: 1823260-2023-03937
• Device Sequence Number: 6115210
• Product Code: CEK
• UDI-Device Identifier: 07613336121528
• UDI-Public: 07613336121528
• Combination Product (Y/N): Y
• Initial Reporter Country: AS
• 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
• Report Date (Section B): 12/11/2023

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: 08058652190
• Device Lot Number: ASKU
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 11/16/2023
• Initial Report FDA Received Date: 12/11/2023
• 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