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

Catalog Number	06473245001
Medical Device Problem Code	Incorrect, Inadequate or Imprecise Result or Readings (1535)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/04/2024
Type of Reportable Event	Malfunction
Event or Problem Description
We received an allegation about discrepant results for 1 patient samples tested with creatinine plus ver.2 (crep2) assay on a cobas 8000 c702 analyzer.Initial result: 36.6 umol/l.The physician questioned the result and requested a repeat of the sample.Repeat result: 82.2 umol/l.
Additional Manufacturer Narrative
The crep2 reagent lot number and expiration date were not provided.The field service engineer (fse) found that a tube on the rinse station had a pinhole.Droplets from the leaky/blocked cell rinse waste were contaminating the cuvettes and influencing the reaction.The tubes are also getting clogged/worn out over time.The fse trimmed the pinched tube and refitted it back.He also checked the gear pump head and the probes and adjusted them.A hardware check, calibration, and qc were performed and they were successful.The root cause was consistent with a maintenance issue.The service actions (trimming the pinched tube and refitting it back) resolved the issue.No further issues were reported afterward.

• 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: 18788829
• Report Number: 1823260-2024-00556
• Device Sequence Number: 12716385
• Product Code: JJE
• UDI-Device Identifier: 04015630930845
• UDI-Public: 04015630930845
• Combination Product (Y/N): Y
• Initial Reporter Country: UK
• 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
• Report Date (Section B): 02/27/2024

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: 02/05/2024
• Initial Report FDA Received Date: 02/27/2024
• 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