MAUDE Adverse Event Report: ROCHE DIAGNOSTICS COBAS 6000 C (501) MODULE; CLINICAL CHEMISTRY ANALYZER

Model Number	C501
Medical Device Problem Code	High Test Results (2457)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/10/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The field service engineer (fse) inspected the module and found the sipper nozzle to be worn.He then replaced the sipper nozzle.He performed mechanical and instrument checks with successful results.The customer performed calibration and qc with successful results.After service, no further issues were reported by the customer.  the investigation determined the service actions resolved the issue.
Event or Problem Description
The initial reporter received questionable ise indirect na, k and ci for gen.2 results from an unspecified number of patient samples tested on the cobas 6000 c 501 (ul) v.The initial results were reported outside of the laboratory.The reporter stated that on (b)(6) 2023 at around noon, they had difficulty calibrating the na assay.They then changed the "reagents" and were able to perform a successful calibration and qc.They ran patient samples that night when a doctor called questioning a na result that was too high in comparison with the point of care (poc) result.The reporter then reran the patient sample on the other module and a result discrepancy was noted.They then reran other patient samples on their two other c501 modules and noted multiple discrepant na, and possibly a few k and cl results.The reporter was able to provide two examples of discrepant na results.Patient sample 1: the initial result from the module was 148 mmol/l.The repeat result from one of the two other c501 modules was 140 mmol/l.Patient sample 1: the initial result from the module was 147 mmol/l.The repeat result from one of the two other c 501 modules was 139 mmol/l.The reporter stated that the results from the other two c 501 modules were in agreement with the poc analysis.The na electrode lot number is 16947.
Additional Manufacturer Narrative
In mfr report ref #1823260-2023-01869-00, the 5th statement should have been: "patient sample 2: the initial result from the module was 147 mmol/l.The repeat result from one of the two other c 501 modules was 139 mmol/l." instead of: "patient sample 1: the initial result from the module was 147 mmol/l.The repeat result from one of the two other c 501 modules was 139 mmol/l.".

• Brand Name: COBAS 6000 C (501) 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; na; ibaraki 312-8 504; JA 312-8504
• Manufacturer Contact: amy nelson ; 9115 hague road; na; indianapolis, IN 46250 ; 3174767531
• MDR Report Key: 17073105
• Report Number: 1823260-2023-01869
• Device Sequence Number: 6129736
• Product Code: JJE
• UDI-Device Identifier: 04015630940806
• UDI-Public: 04015630940806
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K060373
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional,User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 06/07/2023

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 Model Number: C501
• Device Catalogue Number: 05860636001
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/11/2023
• Supplement Date Received by Manufacturer: 05/11/2023
• Initial Report FDA Received Date: 06/06/2023
• Supplement Report FDA Received Date: 06/07/2023
• 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