MAUDE Adverse Event Report: ROCHE DIAGNOSTICS COBAS 8000 C 701 MODULE; CLINICAL CHEMISTRY ANALYZER

Catalog Number	05641489001
Medical Device Problem Code	Incorrect Measurement (1383)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/11/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The c701 module serial number was (b)(4) on (b)(6) 2023 the field service engineer (fse) replaced the reagent probes and adjusted the reagent pipettors.Based on the results from a hardware performance check the fse made adjustments to the rinse unit and replaced the gear pump head.The investigation is ongoing.
Event or Problem Description
The initial reporter complained of discrepant low results for 2 patient samples tested for ca2 on a cobas 8000 c 701 module.On (b)(6) 2023 patient 1 result from the c701 module in question was 1.72 mmol/l.The repeat from a different c701 module was 2.30 mmol/l.On (b)(6) 2023 patient 2 result from the c701 module in question was 1.84 mmol/l.The repeat from a different c701 module was 2.43 mmol/l.The customer repeated the patient samples as the initial results were low compared to the patient¿s previous ca2 results.
Additional Manufacturer Narrative
The ca2 reagent lot number was 744185 with an expiration date of 30-nov-2024.After the first service visit, the customer continued to have questionable results.The specific results were not provided.The field service engineer (fse) returned to the customer site and replaced the heat cut filter, the lens and window and the degasser for the incubation bath.Calibration and qc were acceptable.Based on a review of worldwide data of qc recovery for the reagent/control combination used by the customer, a reagent issue was excluded.The service actions resolved the issue.

• Brand Name: COBAS 8000 C 701 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; ibaraki 312-8 504; JA 312-8504
• Manufacturer Contact: amy nelson ; 9115 hague road; indianapolis, IN 46250-0457
• MDR Report Key: 18388029
• Report Number: 1823260-2023-04166
• Device Sequence Number: 2759662
• Product Code: JJE
• UDI-Device Identifier: 04015630928255
• UDI-Public: 04015630928255
• Combination Product (Y/N): Y
• Initial Reporter Country: GM
• 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: Foreign,Health Professional,User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 01/16/2024
• 2 Devices were Involved in the Event: 1 2

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: 11/30/2024
• Device Catalogue Number: 05641489001
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 12/12/2023
• Supplement Date Received by Manufacturer: 12/28/2023
• Initial Report FDA Received Date: 12/22/2023
• Supplement Report FDA Received Date: 01/16/2024
• 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