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

Catalog Number	08463662001
Medical Device Problem Code	Low Test Results (2458)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/20/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The reagent lot number was 70234801 with an expiration date of 30-apr-2024.The sample was centrifuged for 5 minutes at 4700 rpm.It is recommended that plasma tubes be gently inverted 180º and back 8-10 times and centrifuged at = 1300g for 10 minutes at 25ºc room temperature.The customer's qc was ok.Sample probe abnormal aspiration and sample foam detection alarms were observed, which can indicate poor sample quality.The field service representative found a dripping nozzle on the rinse mechanism.He replaced the solenoid valves.After service, no issues were reported by the customer.The investigation determined the service actions resolved the issue.
Event or Problem Description
There was an allegation of questionable glucose hk gen.3 results for 1 patient sample on a cobas c 503 module.The initial result was 58.6 mg/dl.The customer's middleware rounded the result to 59 mg/dl.The initial result was questioned by the physician and the sample was repeated.The repeated results were 97.6 mg/dl and 97.6 mg/dl.The repeated results were believed to be correct.The second repeated result was obtained on another analyzer.

• 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: 18720116
• Report Number: 1823260-2024-00456
• Device Sequence Number: 7231656
• Product Code: JJE
• UDI-Device Identifier: 07613336158784
• UDI-Public: 07613336158784
• Combination Product (Y/N): Y
• Initial Reporter State: FL
• 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
• Report Date (Section B): 02/16/2024

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: 01/22/2024
• Initial Report FDA Received Date: 02/16/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• 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