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

Model Number	COBAS 8000 ISE
Medical Device Problem Code	High Test Results (2457)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/14/2022
Type of Reportable Event	Malfunction
Event or Problem Description
The initial reporter stated they received discrepant results for two patient samples, tested with ise indirect k for gen.2 on a cobas 8000 ise 1800 module.Patient 1: on (b)(6) 2022, the patient sample was initially measured on a vista analyzer in a different hospital, resulting in a k value of 5.4 mmol/l.An aliquot from this blood drawing was provided to the customer's laboratory and re-measured on two different instrument lines.This medwatch will cover line 1 of the instrument (1990-01).Refer to medwatch with a1 patient identifier: (b)(6) for line 2 of the instrument (1990-02).On (b)(6) 2022, the aliquot of the sample was run on line 1, ise 1 module, resulting in a k value of 6.0 mmol/l.After re-calibration, the sample was repeated on line 1, ise 1 module, and ise 2 module, resulting in k values of 5.7 mmol/l and 5.9 mmol/l.The initial result obtained on the vista analyzer was deemed correct.No questionable result was reported outside of the laboratory.Refer to the attached data "pt-74745_pt-74746" for additional results obtained on the different blood draws in the hospital and the respective aliquots in the customer's laboratory.During troubleshooting in the customer's laboratory, a second sample from a different patient generated different results when comparing the k values obtained on instrument line 1 and 2.Patient 2: on (b)(6) 2022, the sample initially resulted in a k value of 5.9 mmol/l and repeated as 6.0 mmol/l on line 1.The sample was repeated on line 2, resulting in a k value of 5.2 mmol/l.The result of 5.2 mmol/l was deemed correct.No questionable result was reported outside of the laboratory.The k electrode lot numbers were f5865 and f5745 with expiration dates of 24-jan-2023.
Additional Manufacturer Narrative
System pressure and wash were checked.Precision studies were performed and were acceptable.The investigation is ongoing.
Additional Manufacturer Narrative
The last calibration performed on (b)(6) 2022 was acceptable, showing calibration alarms for k on one channel of the analyzer.Quality control recovery was within specifications.Based on the provided information it is not possible to determine if the customer¿s pre-analytical sample handling is acceptable and according to the tube manufacturer¿s recommendations.The field service engineer checked the system pressure and wash on the instrument.He performed precision testing with acceptable results.The analyzer was confirmed to be running back within specifications.The issue did not reoccur.The investigation could not identify a product problem.The 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: 15600690
• Report Number: 1823260-2022-03157
• Device Sequence Number: 16662057
• Product Code: JJE
• UDI-Device Identifier: 08430215011539
• UDI-Public: 08430215011539
• 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): 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): 12/28/2022

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: 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: 09/16/2022
• Supplement Date Received by Manufacturer: 12/02/2022
• Initial Report FDA Received Date: 10/13/2022
• Supplement Report FDA Received Date: 12/28/2022
• 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
• Concomitant Medical Products and Therapy/Usage Dates: PATIENT 1 - ATROVASTATIN; PATIENT 1 - BISOPROLOL FUMARATE; PATIENT 1 - CLARITHROMYCIN; PATIENT 1 - COLCHICINE; PATIENT 1 - FUROSEMIDE; PATIENT 1 - GLYBURIDE; PATIENT 1 - LISINOPRIL; PATIENT 1 - METFORMIN; PATIENT 1 - METROPROLOL SUCCINATE; PATIENT 1 - MUPIROCIN; PATIENT 1 - OLOPATADINE; PATIENT 1 - SPIRONOLACTONE; PATIENT 1 - WARFARIN; PATIENT 2 - DICYCLOMINE; PATIENT 2 - GABAPENTIN; PATIENT 2 - MELOXICAM; PATIENT 2 - TRAZODONE; PATIENT 2 - ZOLOFT
• Patient Sex: Male