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

Catalog Number	06473245001
Medical Device Problem Code	Non Reproducible Results (4029)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/01/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The reagent lot number was 766130, the expiration date was not provided.The investigation is ongoing.
Event or Problem Description
There was an allegation of questionable creatinine (crep2) results from four patient samples tested on a cobas 8000 c702 module.Sample 01: the initial result was 3.29 mg/dl and the repeat result was 1.02 mg/dl.Sample 02: the initial result was 1.13 mg/dl and the repeat result was 0.83 mg/dl.Sample 03: the initial result was 0.69 mg/dl and the repeat result was 1.16 mg/dl.Sample 04: the initial result was 1.32 mg/dl and the repeat result was 0.88 mg/dl.
Additional Manufacturer Narrative
The requested information was not provided and the allegation could not be confirmed.The investigation did not identify a product problem.

• 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: 18796202
• Report Number: 1823260-2024-00566
• Device Sequence Number: 7341974
• Product Code: JJE
• UDI-Device Identifier: 04015630930845
• UDI-Public: 04015630930845
• Combination Product (Y/N): Y
• Initial Reporter Country: IS
• 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): 05/15/2024

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): Follow-Up
• Initial Date Received by Manufacturer: 02/01/2024
• Supplement Date Received by Manufacturer: 05/07/2024
• Initial Report FDA Received Date: 02/28/2024
• Supplement Report FDA Received Date: 05/15/2024
• 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