MAUDE Adverse Event Report: ROCHE DIAGNOSTICS COBAS 8000 C 702 MODULE; CLINICAL CHEMISTRY ANALYZER

Catalog Number	06473245001
Medical Device Problem Code	Low Test Results (2458)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/12/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The calcium reagent lot number is 726309.The expiration date was not provided.The field service engineer (fse) cleaned all probes and the rinse unit and replaced the gear pump tubing.The service maintenance actions performed by the fse resolved the issue.
Event or Problem Description
There was an allegation of questionable ca2 calcium gen.2 results for 9 patient samples on a cobas 8000 c702 module.For sample 1, the initial calcium result was 1.61 mg/dl.The sample was repeated on another (b)(6) analyzer and the result was 6.36 mg/dl.For sample 2, the initial calcium result was 8.83 mg/dl.The sample was repeated on another (b)(6) analyzer and the result was 10.83 mg/dl.For sample 3, the initial calcium result was 6.21 mg/dl.The sample was repeated on another (b)(6) analyzer and the result was 8.72 mg/dl.For sample 4, the initial calcium result was 5.56 mg/dl.The sample was repeated on another (b)(6) analyzer and the result was 8.84 mg/dl.For sample 5, the initial calcium result was 7.18 mg/dl.The sample was repeated on another (b)(6) analyzer and the result was 8.8 mg/dl.For sample 6, the initial calcium result was 5.61 mg/dl.The sample was repeated on another (b)(6) analyzer and the result was 8.0 mg/dl.For sample 7, the initial calcium result was 5.01 mg/dl.The sample was repeated on another (b)(6) analyzer and the result was 8.58 mg/dl.For sample 8, the initial calcium result was 8.29 mg/dl.The sample was repeated on another (b)(6) analyzer and the result was 9.52 mg/dl.For sample 9, the initial calcium result was 3.62 mg/dl.The sample was repeated on another (b)(6) analyzer and the result was 9.05 mg/dl.The repeat results were deemed correct.

• Brand Name: COBAS 8000 C 702 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: 18601720
• Report Number: 1823260-2024-00252
• Device Sequence Number: 18423943
• Product Code: JJE
• UDI-Device Identifier: 04015630930845
• UDI-Public: 04015630930845
• Combination Product (Y/N): Y
• Initial Reporter Country: TH
• 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: Foreign,Health Professional,User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 01/29/2024

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: 06473245001
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 01/13/2024
• Initial Report FDA Received Date: 01/29/2024
• 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