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

Catalog Number	06473245001
Medical Device Problem Code	High Test Results (2457)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/19/2024
Type of Reportable Event	Malfunction
Event or Problem Description
There was an allegation of questionable crep2 creatinine plus ver.2 and ureal urea/bun results for 1 patient sample on a cobas 8000 c702 module.The initial creatinine result was 7.25 mg/dl and the initial urea result was 130.2 mg/dl.The sample was re-centrifuged and repeated on the same analyzer.The repeat creatinine results were 4.60 mg/dl with flag and 4.62 mg/dl with flag and the repeat urea result was 89.5 mg/dl with flag.The next day, the patient had a new sample collected and the creatinine result was 0.84 mg/dl and the urea result was 39.60 mg/dl with flag.The results from the new sample were deemed correct.
Additional Manufacturer Narrative
The creatinine reagent lot number is 75442501 and has an expiration date of 31-jul-2024.The urea reagent lot number is 74134601 and has an expiration date of 30-apr-2024.The qc recovery data provided was acceptable.The field service engineer (fse) replaced and recalibrated the sample and reagent probes.The investigation is ongoing.
Additional Manufacturer Narrative
Based on the calibration and qc data, a general reagent issue could be excluded.The service maintenance actions performed by the fse resolved the issue.No further issues were reported after the service visit.

• 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: 18711290
• Report Number: 1823260-2024-00446
• Device Sequence Number: 7186887
• Product Code: JJE
• UDI-Device Identifier: 04015630930845
• UDI-Public: 04015630930845
• Combination Product (Y/N): Y
• Initial Reporter Country: IT
• 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): 04/29/2024

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: 01/22/2024
• Supplement Date Received by Manufacturer: 04/09/2024
• Initial Report FDA Received Date: 02/15/2024
• Supplement Report FDA Received Date: 04/29/2024
• 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