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	01/31/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
No reagent lot numbers with expiration dates were provided.Reagent issues were excluded as the customer had no further issues and the correct repeat result was received using the same reagent.Qc was acceptable.On 01-feb-2024 the field service engineer (fse) visited the customer site and found leaky cell rinse tubes.The fse replaced the whole set of tubes and confirmed the tests and the module were performing within specification.The service actions resolved the issue.
Event or Problem Description
The initial reporter complained of intermittent questionable results on a cobas 8000 c 702 module.Discrepant results were provided for 3 patient samples tested for either crep2 or ca2.Patient (b)(6) initial crep2 result was 128 umol/l.This result failed a delta check in the infinity software and the sample was repeated with a result of 82 umol/l.The sample was repeated on a different c702 module with a result of 83 umol/l.Patient (b)(6) initial crep2 result was 111 umol/l.The repeat result was 76 umol/l.Patient (b)(6) initial ca2 result was 0.75 mmol/l.The clinicians contacted the customer indicating this result did not correspond to the patient¿s medical profile.The repeat result was 2.56 mmol/l.

• 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: 18651957
• Report Number: 1823260-2024-00340
• Device Sequence Number: 20902002
• Product Code: JJE
• UDI-Device Identifier: 04015630930845
• UDI-Public: 04015630930845
• Combination Product (Y/N): Y
• Initial Reporter Country: DA
• 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): 02/06/2024

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: 01/31/2024
• Initial Report FDA Received Date: 02/06/2024
• 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