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

Model Number	C503
Medical Device Problem Codes	Low Test Results (2458); Non Reproducible Results (4029)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/20/2022
Type of Reportable Event	Malfunction
Event or Problem Description
The initial reporter received a questionable tp2 total protein gen.2 result from one patient sample tested on the cobas pro c 503 analytical unit.The initial result was reported outside of the laboratory.The technician questioned the result after reporting it, which prompted the rerun of the patient sample.The initial result was 3.2 g/dl.The repeat result was 6.4 g/dl.The repeat result was deemed correct.  the reagent lot number is 65383601.The expiration date is 31-oct-2023.
Additional Manufacturer Narrative
The last calibration performed on (b)(6) 2022 was within specifications.Only the qc level 1 recovery was provided.The qc level 1 was acceptable.The customer provided verbally that their qc recovery was acceptable before and after the event.The alarm trace contained "abnormal aspiration (sample pipetter s1)" and "sample foam detection" errors.These are indicators of possible poor sample quality.The field service engineer (fse) inspected the analyzer and could not find any cause for the reported issue, but noted that there was dried serum in one of the sample probes.He then cleaned the inside of this probe.He also checked the horizontal adjustments and the probe rinse.The customer performed qc and precision tests with successful results.After service, no further issues were reported by the customer.  the investigation determined the service actions resolved the issue.  the cause of the event could not be determined.

• 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; na; ibaraki 312-8 504; JA 312-8504
• Manufacturer Contact: amy nelson ; 9115 hague road; na; indianapolis, IN 46250 ; 3174767531
• MDR Report Key: 16197740
• Report Number: 1823260-2023-00164
• Device Sequence Number: 6066367
• Product Code: JJE
• UDI-Device Identifier: 07613336121528
• UDI-Public: 07613336121528
• Combination Product (Y/N): N
• 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): 01/18/2023

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 Model Number: C503
• Device Catalogue Number: 08463662001
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/22/2022
• Initial Report FDA Received Date: 01/18/2023
• 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
• Patient Age: 43 YR
• Patient Sex: Male
• Patient Weight: 123 KG