MAUDE Adverse Event Report: ROCHE DIAGNOSTICS COBAS 8000 ISE 1800 MODULE; CLINICAL CHEMISTRY ANALYZER

Model Number	COBAS 8000 ISE
Medical Device Problem Codes	Incorrect Measurement (1383); Insufficient Device Problem Information (3190)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/16/2023
Type of Reportable Event	Malfunction
Event or Problem Description
There was an allegation of questionable gen.2 ise indirect for na and cl results for 24 patient samples on a cobas 8000 cobas ise module.The customer provided an example of discrepant results for 1 patient sample.The initial na result was 150 mmol/l and the initial cl result was 92 mmol/l.The initial results were reported outside of the laboratory.The customer was prompted to repeat the sample as they started receiving voltage-level errors and high results.The sample was repeated and the na result was 140 mmol/l and the cl result was 104 mmol/l.The repeat results were deemed correct.The electrode lots and expiration dates were requested but not provided.
Additional Manufacturer Narrative
The customer primed the ises, recalibrated, and repeated qc.The investigation is ongoing.
Additional Manufacturer Narrative
Calibration was last performed on (b)(6) 2023.The alarm trace showed voltage level errors, abnormal aspiration, and abnormal sample probe aspiration alarms on the day of the event.The root cause of the event could not be determined.

• Brand Name: COBAS 8000 ISE 1800 MODULE
• 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: 16753551
• Report Number: 1823260-2023-01281
• Device Sequence Number: 14269069
• Product Code: JJE
• UDI-Device Identifier: 04015630908684
• UDI-Public: 04015630908684
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K100853
• 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): 05/15/2023

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: COBAS 8000 ISE
• Device Catalogue Number: 05964075001
• 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: 03/20/2023
• Supplement Date Received by Manufacturer: 04/19/2023
• Initial Report FDA Received Date: 04/17/2023
• Supplement Report FDA Received Date: 05/15/2023
• 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