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

Catalog Number	08463662001
Medical Device Problem Code	Incorrect, Inadequate or Imprecise Result or Readings (1535)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/27/2023
Type of Reportable Event	Malfunction
Event or Problem Description
The initial reporter questioned the results for multiple assays and multiple patient samples tested on a cobas c 503 analytical unit.Discrepant results were provided for 2 patient samples tested for alb bcg gen.2 (alb2), crphs, and magnesium reagent (mg2).Patient 1 initial alb2 result was 5.02 g/dl.The repeat result was 3.66 g/dl.Patient 2 initial crphs result was 5.95 mg/l.The repeat result was 37.8 mg/l.The initial mg2 result was 3.39 mg/dl.The repeat result was 2.06 mg/dl.No questionable results were reported outside of the laboratory.The samples were repeated on a different c503 analyzer.The repeat results were believed to be correct.
Additional Manufacturer Narrative
The alb2 reagent lot number was 74634701 with an expiration date of 30-nov-2024.The crphs reagent lot number was 69279501 with an expiration date of 30-sep-2024.The mg2 reagent lot number was 70737801 with an expiration date of 30-nov-2024.The field service engineer (fse) found the photometer lens inside the lens holder was askew.The fse replaced the cuvettes, the lamp, and the heat-cut filter and reassembled the lens holder assembly.The fse found an issue with a valve and replaced it.The customer had no further issues after the valve was replaced.Calibration was acceptable.The customer¿s qc data provided appears to be acceptable.The customer used a sample spin time of 7 minutes at a speed of 4500 revolutions per minute (rpm).This spin time may be shorter than recommended and the spin speed may be faster than recommended.Multiple photometer check alarms were observed on the alarm trace data.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; ibaraki 312-8 504; JA 312-8504
• Manufacturer Contact: amy nelson ; 9115 hague road; indianapolis, IN 46250
• MDR Report Key: 18468319
• Report Number: 1823260-2024-00084
• Device Sequence Number: 12541964
• Product Code: JJE
• UDI-Device Identifier: 07613336158784
• UDI-Public: 07613336158784
• Combination Product (Y/N): Y
• Initial Reporter State: MA
• 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): N
• Reporter Type: Manufacturer
• Report Source: Health Professional,User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 01/08/2024

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: 08463662001
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 12/27/2023
• Initial Report FDA Received Date: 01/08/2024
• 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
• Concomitant Medical Products and Therapy/Usage Dates: PATIENT 1 ¿ UNSPECIFIED COPD MEDICATIONS; PATIENT 2 ¿ ACETAMINOPHEN; PATIENT 2 ¿ PREDNISOLONE
• Patient Age: 61 YR
• Patient Sex: Male
• Patient Weight: 122 KG