MAUDE Adverse Event Report: ROCHE DIAGNOSTICS COBAS INTEGRA 400 PLUS ANALYZER; CLINICAL CHEMISTRY ANALYZER

Model Number	I400+
Medical Device Problem Codes	Incorrect Measurement (1383); Non Reproducible Results (4029)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/31/2022
Type of Reportable Event	Malfunction
Event or Problem Description
The initial reporter stated they received discrepant results for three patient samples tested with the na+ electrode on a cobas integra 400 plus.No incorrect results were reported outside of the laboratory.The first sample initially resulted in a na value of 126 mmol/l and repeated with a value of 132 mmol/l.The second sample initially resulted in a na value of 118 mmol/l and repeated with a value of 138 mmol/l.The third sample initially resulted in a na value of 120 mmol/l and repeated with a value of 140 mmol/l.The na electrode lot number and expiration date were requested, but not provided.
Additional Manufacturer Narrative
The field service engineer determined the ise module had an initialization problem.The ise mixing tower and a system reagent were changed.The electrode block and seals were checked.The ise tubing was refitted and verified to be seated correctly into the valves.Calibrator solution was primed and a sensor was checked.Calibration and controls were ok.The issue was corrected after the service actions.The investigation could not identify a product problem.The cause of the event could not be determined.

• Brand Name: COBAS INTEGRA 400 PLUS ANALYZER
• Common Device Name: CLINICAL CHEMISTRY ANALYZER
• Manufacturer (Section D): ROCHE DIAGNOSTICS; 9115 hague road; indianapolis IN 46250 0457
• Manufacturer (Section G): ROCHE INSTRUMENT CENTER AG TEGIMENTA; forrenstrasse; na; rotkreuz 6343 ; SZ 6343
• Manufacturer Contact: amy nelson ; 9115 hague road; na; indianapolis, IN 46250 ; 3174767531
• MDR Report Key: 15770121
• Report Number: 1823260-2022-03570
• Device Sequence Number: 17764813
• Product Code: JJE
• UDI-Device Identifier: 04015630032457
• UDI-Public: 04015630032457
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• PMA/510(K) Number: K951595
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 11/30/2022

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: I400+
• Device Catalogue Number: 03245233001
• 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: 10/31/2022
• Supplement Date Received by Manufacturer: 11/17/2022
• Initial Report FDA Received Date: 11/10/2022
• Supplement Report FDA Received Date: 11/30/2022
• 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