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	12/27/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The reagent lot number is 74416901 and the expiration date is 30-nov-2024.Calibration was last performed on 11-dec-2023.The qc recovery data provided was acceptable.It was found that the customer centrifuges patient samples for 3 minutes at 5100 rpm, which may be too short and too fast.The alarm trace showed an abnormal aspiration alarm.The field service egnineer (fse) found that the cell rinse was overfilling.The fse adjusted the cell rinse volume, checked the rinse tubing, and performed a hardware and precision check.The customer performed qc successfully.The service maintenance actions performed by the fse resolved the issue.No further issues were reported after the service visit.
Event or Problem Description
There was an allegation of questionable ca2 calcium gen.2 results for 1 patient sample on a cobas pro c 503 analytical unit.The initial ca2 result was 5.1 mg/dl.The customer questioned the low result as it did not match the patient's previous result and repeated the sample.The sample was repeated on another cobas pro analyzer and the result was 8.6 mg/dl.The repeat result was deemed correct.No questionable results were reported outside of he laboratory.

• 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: 18445085
• Report Number: 1823260-2024-00034
• Device Sequence Number: 15141381
• Product Code: JJE
• UDI-Device Identifier: 07613336158784
• UDI-Public: 07613336158784
• Combination Product (Y/N): Y
• Initial Reporter State: WI
• 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): 01/04/2024

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: 01/04/2024
• 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