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

Model Number	C503
Medical Device Problem Code	Low Test Results (2458)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/24/2022
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The field service engineer determined the halogen lamp degraded.The lamp was replaced.Diagnostic checks were performed.The customer ran controls and the results were approved.
Event or Problem Description
The initial reporter stated they performed maintenance on the cobas pro c 503 on 22-nov-12022 and controls run for altlp alanine aminotransferase acc.To ifcc with pyridoxal phosphate activation passed after the maintenance.Controls started recovering erratically and failed on 25-nov-2022.The operator calibrated the alt reagent pack and controls were acceptable.An unspecified number of patient samples were repeated and results for some samples were corrected.The customer provided data for one patient sample with discrepant alt results.This sample initially resulted in an alt value of 5 u/l and this value was reported outside of the laboratory.The sample was repeated on 25-nov-2022, resulting in a value of 32 u/l.The repeat value was deemed correct and a corrected report was issued.The alt reagent lot number was 66105201, with an expiration date of 30-nov-2023.
Additional Manufacturer Narrative
The last calibration performed on (b)(6) 2022 was ok and there were no alarms.Quality controls were within the customer's range on the day of the event.The investigation determined the service actions resolved the issue.

• 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: 15959887
• Report Number: 1823260-2022-03970
• Device Sequence Number: 11996557
• Product Code: JJE
• UDI-Device Identifier: 07613336120989
• UDI-Public: 07613336120989
• Combination Product (Y/N): N
• Initial Reporter Country: US
• 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: Health Professional,User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 02/09/2023

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: 11/29/2022
• Supplement Date Received by Manufacturer: 01/19/2023
• Initial Report FDA Received Date: 12/12/2022
• Supplement Report FDA Received Date: 02/09/2023
• 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 Age: 28 YR
• Patient Sex: Female