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

Catalog Number 08463662001

Device Problem Low Test Results (2458)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 02/27/2024

Event Type  malfunction  

Event Description

There was an allegation of questionable calcium gen.2 results for 1 patient sample on a cobas c 503 analytical unit.The initial result was 6.62 mg/dl.The repeated result was 10.0 mg/dl.The repeated result was believed to be correct.The sample was repeated due to the low initial result.The erroneous result was not reported outside of the laboratory.

Manufacturer Narrative

The reagent lot number is 75546501 with an expiration date of 31-jan-2025.The customer's calibration and qc results were acceptable.The customer's alarm trace contained abnormal aspiration and sample probe abnormal aspiration errors, which are indicative of possible poor sample quality.The field service representative found the main pressure had dropped and the cell rinse mechanism water level was too low.He adjusted the gear pump pressure and adjusted the cell rinse mechanism water level.He verified the instrument by having the customer perform qc successfully.After service, no issues were reported by the customer.The investigation determined the service actions resolved the issue.

• Brand Name: COBAS C 503 ANALYTICAL UNIT
• Type of Device: 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: 18952669
• MDR Text Key: 338270708
• Report Number: 1823260-2024-00854
• Device Sequence Number: 1
• Product Code: JJE
• Combination Product (y/n): Y
• Reporter Country Code: US
• PMA/PMN Number: K191899
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,User Facility
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 03/21/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/21/2024
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 08463662001
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 02/27/2024
• Was Device Evaluated by Manufacturer?: Yes
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Age: 20 YR
• Patient Sex: Male