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	10/11/2022
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The field service engineer (fse) found that calibration results had shifted prior to the shift in qc and patient results.The fse replaced all the reaction cells and flushed all vacuum tubings and a valve.The fse decontaminated the system, adjusted the gear pump pressure back to specification, and verified mechanical adjustments and the rinse volume.The sample probes were also replaced.Instrument and precision checks were performed.The investigation is ongoing.
Event or Problem Description
The initial reporter stated qc was high outside of the acceptable range for tina-quant hemoglobin a1cdx gen.3 (a1cx3) on the cobas c513 analyzer.The customer repeated patient samples that had been run prior to qc being out of range and the results were much lower.The customer stated approximately 100 patient samples needed corrected reports.The customer provided examples of discrepant results for 2 patient samples.Patient 1 initial result was 6.95%.The repeat from a different c513 analyzer was 5.82%.Patient 2 initial result was 12.39%.The repeat from a different c513 analyzer was 9.97%.The initial results were reported outside of the laboratory.The repeat results were believed to be correct.The a1cx3 reagent lot number was 59191001 with an expiration date of 31-mar-2023.
Additional Manufacturer Narrative
The investigation reviewed calibration and qc data and determined it to be within specifications.The investigation determined the event was caused by an abnormal lot calibration.The issue was resolved by recalibrating.The instrument software worked as expected.The investigation did not identify a product problem.

• 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: 15729885
• Report Number: 1823260-2022-03491
• Device Sequence Number: 19565836
• 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): 01/04/2023

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: 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: 10/12/2022
• Supplement Date Received by Manufacturer: 12/29/2022
• Initial Report FDA Received Date: 11/04/2022
• Supplement Report FDA Received Date: 01/04/2023
• 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 Sex: Unknown