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

Model Number	C513
Medical Device Problem Codes	High Test Results (2457); Non Reproducible Results (4029)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/10/2022
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The qc trace showed some high results and the calibration trace showed some errors.The field service engineer (fse) performed instrument checks and found no issues.The investigation found that the customer changed the sample probe on (b)(6) 2022 due to multiple aspiration alarms.The investigation determined that the cause of the event is consistent with insufficient customer maintenance.The investigation did not identify a product problem.
Event or Problem Description
There was an allegation of questionable a1c-2 tina-quant hemoglobin a1c gen.3 results for 1 patient sample on a cobas c513 analyzer commercial system.The initial hemoglobin a1c result was 12.5%.The sample was retested using hplc and the result was 4.9%.The results were reported outside of the laboratory.The reagent lot number is 61196701.The expiration date was requested but not provided.

• 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: 15892633
• Report Number: 1823260-2022-03828
• Device Sequence Number: 17445459
• Product Code: JJE
• UDI-Device Identifier: 04015630942787
• UDI-Public: 04015630942787
• Combination Product (Y/N): N
• Initial Reporter Country: BR
• 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: Foreign,Health Professional,User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 12/01/2022

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: 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: 11/07/2022
• Initial Report FDA Received Date: 12/01/2022
• 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
• Patient Sex: Unknown