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

Catalog Number	05641489001
Medical Device Problem Code	Low Test Results (2458)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/24/2023
Type of Reportable Event	Malfunction
Event or Problem Description
There was an allegation of questionable results from the cobas 8000 cobas c 701 module.Patient 1 initial cystatin result was 0.00 mg/l and the repeat result was 0.96 mg/l.Patient 2 initial calcium result was 1.09 mmol/l and the repeat result was 1.92 mmol/l on the same analyzer and 2.52 mmol/l on another c701 analyzer.Patient 3 initial calcium result was 1.82 mmol/l and the repeat result was 1.69 mmol/l on the same analyzer and 2.35 mmol/l on another c701 analyzer.Patient 4 initial calcium result was 1.87 mmol/l and the repeat result was 2.41 mmol/l on the same analyzer.
Additional Manufacturer Narrative
The cystatin reagent lot number was 73522101 with an expiration date of 30-apr-2025.The calcium reagent lot number was 71725901 with an expiration date of 30-jun-2024.The probe for the detergent was found to be dirty with a black deposit on the outside.The investigation is ongoing.
Additional Manufacturer Narrative
The field service engineer replaced the degasser, the incubation bath degasser, and the rinse station tube.The investigation determined 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
• MDR Report Key: 18326528
• Report Number: 1823260-2023-03989
• Device Sequence Number: 20713032
• Product Code: JJE
• UDI-Device Identifier: 04015630928255
• UDI-Public: 04015630928255
• Combination Product (Y/N): Y
• Initial Reporter Country: FR
• 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): 12/15/2023

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 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: Not provided
• Supplement Date Received by Manufacturer: 12/15/2023
• Initial Report FDA Received Date: 12/14/2023
• Supplement Report FDA Received Date: 12/15/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• 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