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

Model Number	I400+
Medical Device Problem Code	Low Test Results (2458)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/30/2022
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Na.
Event or Problem Description
The initial reporter stated they have been having issues with ise tests on the cobas integra 400 plus.They have been receiving ise unstable flags for calibration and control samples throughout the day.They also had issues with na+ electrode calibration over the past few days.The customer tried replacing the na electrode, electrode o-rings, and system reagents.The customer also rolled the peristaltic pump tubing, cleaned the reference tubing of salt buildup at the top of the system reagent bottle, and ran cleaning maintenance.The customer primed, activated, and initialized the ise test several times.The customer replaced the mix tower due to a priming error and ran a new calibration that failed.During the issue, the customer noted they received discrepant na results for four patient samples.No incorrect results were reported outside of the laboratory.The first patient sample initially resulted in a na value of 133.59 mmol/l, which repeated as 142.37 mmol/l.The repeat value was deemed correct.The second patient sample initially resulted in a na value of 129.23 mmol/l, which repeated as 138.03 mmol/l.The repeat value was deemed correct.The third patient sample initially resulted in a na value of 130.71 mmol/l.The sample was repeated twice, resulting in values of 129.66 mmol/l and 135.07 mmol/l.The highest value was deemed correct.The fourth patient sample initially resulted in a na value of 128.65 mmol/l.The sample was repeated twice, resulting in values of 131.14 mmol/l and 135.38 mmol/l.The highest value was deemed correct.The na electrode lot number was 21520668, with an expiration date of 18-nov-2022.
Additional Manufacturer Narrative
The last calibration performed on (b)(6) 2022 failed, with unstable ise alarms.Controls tested on (b)(6) 2022 were outside of the 2 standard deviations range.Upon review of the alarm trace, an ise controller hardware error was observed.The field service engineer determined that tubing at the peristaltic pump failed.The ise tubing and electrode o-rings were replaced.The ise was primed.The customer ran calibration and controls; all results met specifications.The investigation determined the service actions resolved the issue.

• 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: 15644287
• Report Number: 1823260-2022-03274
• Device Sequence Number: 17634104
• Product Code: JJE
• UDI-Device Identifier: 04015630032457
• UDI-Public: 04015630032457
• Combination Product (Y/N): N
• Initial Reporter Country: US
• 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: Health Professional,User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 12/05/2022

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 Expiration Date: 01/13/2023
• Device Model Number: I400+
• Device Catalogue Number: 03245233001
• Device Lot Number: 21521447
• 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: 09/30/2022
• Supplement Date Received by Manufacturer: 11/17/2022
• Initial Report FDA Received Date: 10/20/2022
• Supplement Report FDA Received Date: 12/05/2022
• 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