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

Model Number	C503
Medical Device Problem Code	High Test Results (2457)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/20/2022
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The field service engineer checked the analyzer pressures, levels, and alignments, and performed a precision check successfully.The customer ran calibration and qc successfully.The investigation is ongoing.
Event or Problem Description
There was an allegation of questionable crej2 creatinine jaffé gen.2 results for 1 patient sample on a cobas pro c 503 analytical unit.On (b)(6) 2022, the initial crej2 result was 2.4 mg/dl.The result was reported outside of the laboratory.The patient's doctor questioned the result as it did not match their previous result.On 21-oct-2022, a new sample was collected and the crej2 result was 0.589 mg/dl.The first sample was repeated and the result was 0.6 mg/dl.The repeat result was deemed correct.The reagent lot number is 627775.The expiration date was requested but not provided.
Additional Manufacturer Narrative
Qc recovery was acceptable.The alarm trace showed multiple abnormal aspiration alarms on the date of the event near the time sample was processed.No further issues were reported after the service visit.The investigation did not identify a product problem.The root 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: 15792596
• Report Number: 1823260-2022-03620
• Device Sequence Number: 5615786
• Product Code: JJE
• UDI-Device Identifier: 07613336121177
• UDI-Public: 07613336121177
• 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,Followup
• Report Date (Section B): 12/20/2022

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: 10/21/2022
• Supplement Date Received by Manufacturer: 12/02/2022
• Initial Report FDA Received Date: 11/14/2022
• Supplement Report FDA Received Date: 12/20/2022
• 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
• Concomitant Medical Products and Therapy/Usage Dates: ASPIRIN; CLARITIN
• Patient Age: 39 YR
• Patient Sex: Female
• Patient Weight: 91 KG