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
Event or Problem Description
We received an allegation about discrepant results for 6 patients' serum/plasma samples tested with creatinine gen.2 (crep2) assay on a cobas 8000 c702 analyzer.Sample 1: on (b)(6) 2024: initial result: 567 umol/l.This result was auto-validated.The questionable result was noticed by chance and the sample was then repeated on the same day.Repeat result: 46 umol/l.The repeat result was deemed to be correct.Sample 2: on (b)(6) 2024: initial result: 112 umol/l.1st repeat result: 70 umol/l.2nd repeat result: 72 umol/l.Sample 3: on (b)(6) 2024: initial result: 424 umol/l.Repeat result: 74 umol/l.Sample 4: on (b)(6) 2024: initial result: 673 umol/l.On (b)(6) 2024: repeat result: 80 umol/l.Sample 5: on (b)(6) 2024: initial result: 263 umol/l.On (b)(6) 2024: repeat result: 61 umol/l.Sample 6: on (b)(6) 2024: initial result: 180 umol/l.Repeat result: 93 umol/l.
Additional Manufacturer Narrative
The crep2 reagent lot number was 751734.The expiration date was not provided.Qc was acceptable.The investigation is ongoing.
Additional Manufacturer Narrative
The customer alleged discrepant results for an additional 2 patient serum samples tested with creatinine gen.2 (crep2) assay.Sample 8 was tested on (b)(6) 2024: initial result: 282 umol/l.The sample was then repeated twice and both results were 101 umol/l.Sample 9 was tested on (b)(6) 2024: initial result: 124 umol/l.Repeat result: 70 umol/l.Qc was acceptable.The investigation is ongoing.
Additional Manufacturer Narrative
The customer alleged discrepant results for an additional patient's serum/plasma sample tested with creatinine gen.2 (crep2) assay.Sample 7: on (b)(6) 2024: initial result: 173 umol/l.On (b)(6) 2024: repeat result: 84 umol/l.The investigation is ongoing.
Additional Manufacturer Narrative
A general reagent issue can be excluded as qc was within ranges.The field service engineer found that the detergent filling level in the reaction cells was too low.He corrected the detergent filling level, adjusted the gear pump pressure, and replaced 2 wash station tubes and valves.The instrument was performing within specifications.No further issues were reported afterward.The root cause was consistent with a maintenance issue.

• 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: 18753696
• Report Number: 1823260-2024-00511
• Device Sequence Number: 11722017
• Product Code: JJE
• UDI-Device Identifier: 04015630930845
• UDI-Public: 04015630930845
• Combination Product (Y/N): Y
• Initial Reporter Country: NO
• 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,Followup,Followup
• Report Date (Section B): 06/07/2024

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: 02/01/2024
• Supplement Date Received by Manufacturer: 02/22/2024; 03/21/2024; 06/05/2024
• Initial Report FDA Received Date: 02/21/2024
• Supplement Report FDA Received Date: 03/15/2024; 04/15/2024; 06/07/2024
• 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