MAUDE Adverse Event Report: ROCHE DIAGNOSTICS TOTAL PROTEIN URINE/CSF GEN.3; URINE/CSF TOTAL PROTEIN TEST

Catalog Number	08058679190
Medical Device Problem Code	Non Reproducible Results (4029)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/13/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The serial number of the cobas pro c 503 analytical unit is (b)(6).The investigation reviewed the last calibration performed on (b)(6) 2024; the results were within specifications.The investigation reviewed the qc data from the analyzer's log files; the results were within specifications.The investigation reviewed the alarm trace (last 30 days) from the analyzer's log files; the most frequent alarm was "abnormal aspiration (sample pipettor s1)" alarm.The investigation is ongoing.
Event or Problem Description
The initial reporter received a questionable tpuc3 (total protein urine/csf gen.3) result from one urine patient sample tested on the cobas c 503 analytical unit.The reporter stated that the microalbumin result of 185 mg/l was inconsistent with the initial tpuc3 result prompting the rerun of the patient sample.The initial result was 0.14 g/l.The first repeat result was 0.45 g/l.The second repeat result was 0.45 g/l.The third repeat result was 0.45 g/l.The fourth repeat result was reported as 0.48 g/l.
Additional Manufacturer Narrative
Medwatch field d4 lot no was updated.On 17-may-2024, the customer provided additional data regarding the event: on (b)(6) 2024: the fifth repeat result was 0.49 g/l.The investigation reviewed the last calibration performed on 04-mar-2024 and the results were within specifications.The investigation reviewed the qc data and the results were within specifications.The investigation reviewed the instrument's log files.The log files had multiple "abnormal aspiration (sample pipettor s1)" alarms.This alarm is an indication of preanalytic/sample handling-related issues.The investigation determined the event was consistent with a preanalytic issue at the customer site.The investigation ruled out a general reagent issue.The investigation did not identify a product problem.

• Brand Name: TOTAL PROTEIN URINE/CSF GEN.3
• Common Device Name: URINE/CSF TOTAL PROTEIN TEST
• 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: 19059821
• Report Number: 1823260-2024-01064
• Device Sequence Number: 20521209
• Product Code: JIQ
• UDI-Device Identifier: 07613336121535
• UDI-Public: 07613336121535
• Combination Product (Y/N): Y
• Initial Reporter Country: FR
• PMA/510(K) Number: K141925
• 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): 07/12/2024

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: 08058679190
• Device Lot Number: 747700
• 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: 03/18/2024
• Supplement Date Received by Manufacturer: 06/21/2024
• Initial Report FDA Received Date: 04/08/2024
• Supplement Report FDA Received Date: 07/12/2024
• 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