MAUDE Adverse Event Report: ROCHE DIAGNOSTICS COBAS C 503 ANALYTICAL UNIT; CLINICAL CHEMISTRY ANALYZER

Model Number	C503
Medical Device Problem Code	Non Reproducible Results (4029)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/07/2022
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The last calibration performed on 21-oct-2022 was acceptable.Quality controls were within specified ranges.Instrument performance testing was completed with results outside of specification.The field service engineer checked the instrument and determined a small crust of serum on the sample probe.He cleaned and adjusted the sample probe.Instrument performance testing was run, which did still not pass within specifications.The investigation is ongoing.
Event or Problem Description
The initial reporter stated they received discrepant results for one urine patient sample tested with tpuc3 (total protein urine/csf gen.3) on a cobas c 503 analytical unit.The sample initially resulted in a tpuc3 value of 0.07 g/l.This result was reported outside of the laboratory and questioned by the physician.The result is inconsistent with the microalbumin result of 273 mg/l of the patient.The sample was repeated on the next day on a second analyzer resulting in a tpuc3 value of 0.35 g/l.This result is consistent with the microalbumin result of 274 mg/l of the patient.The tpuc3 reagent lot was 627560 with an expiration date of 31-aug-2023.
Additional Manufacturer Narrative
The field service engineer adjusted the naoh level and adjusted the ultrasonic mixer.Instrument performance testing was run, which did still not pass within specifications.The investigation is ongoing.
Additional Manufacturer Narrative
Repeatability testing was performed with acceptable results.The issue did not re-occur.A general reagent issue could be excluded.The investigation determined the service actions performed resolved the issue.The issue is consistent with a contaminated sample probe due to improper pre-analytical handling or maintenance by the operator.

• Brand Name: COBAS C 503 ANALYTICAL UNIT
• Common Device Name: CLINICAL CHEMISTRY ANALYZER
• Manufacturer (Section D): ROCHE DIAGNOSTICS; 9115 hague road; indianapolis IN 46250 0457
• Manufacturer (Section G): HITACHI HIGH TECH CORP.; 882 ichige hitachinaka; na; ibaraki 312-8 504; JA 312-8504
• Manufacturer Contact: amy nelson ; 9115 hague road; na; indianapolis, IN 46250 ; 3174767531
• MDR Report Key: 15904113
• Report Number: 1823260-2022-03843
• Device Sequence Number: 5390509
• Product Code: JJE
• UDI-Device Identifier: 07613336121535
• UDI-Public: 07613336121535
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• PMA/510(K) Number: K191899
• 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,Followup
• Report Date (Section B): 01/20/2023

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 Model Number: C503
• Device Catalogue Number: 08463662001
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/09/2022
• Supplement Date Received by Manufacturer: 12/06/2022; 12/27/2022
• Initial Report FDA Received Date: 12/02/2022
• Supplement Report FDA Received Date: 12/27/2022; 01/20/2023
• 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