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

Catalog Number	08463662001
Medical Device Problem Code	Non Reproducible Results (4029)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/07/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The glucose reagent lot number was 747661.The reagent expiration date was requested, but not provided.The field service engineer found visible foreign material on the exterior of the probe tip.The probe was replaced and wash station adjustments were performed.The cell rinse mechanism adjustments were verified.Precision studies were performed and passed.Controls were run and passed.Calibration and controls were acceptable prior to the event.Upon review of the alarm trace, an abnormal aspiration alarm was observed.The investigation determined the service actions resolved the issue.
Event or Problem Description
The initial reporter stated they had to correct results for an unspecified number of patient samples tested for multiple analytes on the cobas c 503 analytical unit on (b)(6)2023.The customer noted they received aspiration errors on the analyzer on (b)(6) 2023, so they cleaned the probe and controls passed on (b)(6) 2023.The customer then noticed several patient samples had low results and these did not agree with the clinical picture of the patients.The customer ran controls and these failed for at least 4 different analytes.The customer repeated 84 patient samples.The customer provided data for one patient sample with discrepant results for glucose hk gen.3.This sample initially resulted in a glucose value of 100 mg/dl.The sample was repeated on a second analyzer, resulting in a glucose value of 70 mg/dl.The repeat value was deemed correct.

• 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: 18730233
• Report Number: 1823260-2024-00471
• Device Sequence Number: 12540526
• Product Code: JJE
• UDI-Device Identifier: 07613336158784
• UDI-Public: 07613336158784
• Combination Product (Y/N): Y
• Initial Reporter State: MO
• 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): 02/19/2024

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: 02/12/2024
• Initial Report FDA Received Date: 02/19/2024
• 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