MAUDE Adverse Event Report: ROCHE DIAGNOSTICS COBAS C 513 ANALYZER; CLINICAL CHEMISTRY ANALYZER

Model Number	C513
Medical Device Problem Code	High Test Results (2457)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/24/2022
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The field service engineer found no problem with the system.He completed checks, alignments, and pressures.The customer ran passing qc with fresh reagents and all checks passed.The investigaiton is ongoing.
Event or Problem Description
There was an allegation of a questionable hemoglobin a1c result from the cobas c513 analyzer.The initial result was 7.2% and was reported outside of the laboratory.The physician called and questioned the result because past results for this patient had been closer to 5.0%.On 30-dec-2022, the customer repeated the sample and the result was 5.0%.The reagent lot number was 62958001 with an expiration date of 31-aug-2023.
Additional Manufacturer Narrative
The investigation did not identify a product problem.The cause of the event could not be determined.The analyzer alarm trace contained multiple reagent short alarms during the timeframe of the event.The qc recovery was acceptable.Therefore there was no indication of a performance issue with the reagent or instrument.

• Brand Name: COBAS C 513 ANALYZER
• 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: 16213818
• Report Number: 1823260-2023-00192
• Device Sequence Number: 14550931
• Product Code: JJE
• UDI-Device Identifier: 04015630942787
• UDI-Public: 04015630942787
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K060373
• 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): 03/17/2023

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 Expiration Date: 08/31/2023
• Device Model Number: C513
• Device Catalogue Number: 07649142001
• 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: 01/04/2023
• Supplement Date Received by Manufacturer: 03/09/2023
• Initial Report FDA Received Date: 01/20/2023
• Supplement Report FDA Received Date: 03/17/2023
• 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: Female