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	11/22/2022
Type of Reportable Event	Malfunction
Event or Problem Description
The initial reporter complained of discrepant results for 1 patient sample tested for lithium (li) on a cobas pro c 503 analytical unit.The initial result was 1.28 mmol/l with a data flag.The repeat result was 0.00524 mmol/l with a data flag.The customer repeated the sample 5 times with results of 0.0173 mmol/l with a data flag, 0.0190 mmol/l with a data flag, 0.0183 mmol/l with a data flag, 0.0141 mmol/l with a data flag, and 0.0160 mmol/l with a data flag.The repeat results were reported outside of the laboratory.It is not clear which results were believed to be correct.The li reagent lot number was 59094201 with an expiration date of 30-sep-2023.
Additional Manufacturer Narrative
The customer performs qc daily with acceptable results.The investigation is ongoing.
Additional Manufacturer Narrative
The field service engineer checked the rinse water volume and reported everything is ok.The investigation could not identify a product problem.The cause of the event could not be determined.

• 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: 15991887
• Report Number: 1823260-2022-04030
• Device Sequence Number: 20332383
• Product Code: JJE
• UDI-Device Identifier: 07613336121382
• UDI-Public: 07613336121382
• Combination Product (Y/N): N
• Initial Reporter Country: HR
• 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
• Report Date (Section B): 02/17/2023

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: 11/22/2022
• Supplement Date Received by Manufacturer: 01/30/2023
• Initial Report FDA Received Date: 12/15/2022
• Supplement Report FDA Received Date: 02/17/2023
• 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