MAUDE Adverse Event Report: ROCHE DIAGNOSTICS COBAS 6000 C501 MODULE; CLINICAL CHEMISTRY ANALYZER

Model Number	C501
Medical Device Problem Code	Non Reproducible Results (4029)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/05/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
A first precision study performed on (b)(6)2023 was not acceptable.A second precision study performed on (b)(6)2023 was acceptable.A photometer check and cell blank measurement were performed and these were ok.All necessary carry-over evasion washes have been installed on the analyzer.No product issue was found in relation to the reagent.On (b)(6)2023, the field service engineer performed mechanism checks and observed no physical obstructions.The vacuum lines were cleaned to improve suction.The probes were cleaned and their adjustments were checked.The fill nozzles and gear pump pressure were checked.Precision studies were acceptable.The rinse water was adjusted.Quality controls were within range.There have been no further issues after these actions.
Event or Problem Description
The initial reporter stated they received questionable results for three patient samples tested on a cobas 6000 c (501) module.No questionable results were reported outside of the laboratory.Results for the following assays were affected: ise indirect na, k, ci for gen.2 and astlp aspartate aminotransferase acc.To ifcc with pyridoxal phosphate activation.The complained sample from the first patient resulted in the following values: na results = 123 mmol/l with a data flag on (b)(6)2023; 141 mmol/l, 142 mmol/l, 143 mmol/l, and 143 mmol/l on (b)(6)2023; 144 mmol/l and 143 mmol/l on 07-feb-2023.K results = 3.68 mmol/l on (b)(6)2023; 4.33 mmol/l and 4.29 mmol/l on (b)(6)2023 ; 4.31 mmol/l and 4.28 mmol/l on 07-feb-2023.Cl results = 90.6 mmol/l with a data flag on 05-feb-2023; 106 mmol/l, 104.3 mmol/l, 104.8 mmol/l, and 105.2 mmol/l on (b)(6)2023; 104.7 mmol/l and 104.3 mmol/l on (b)(6)2023.The sample probe was changed and questionable results were then observed for the remaining samples.The complained sample from the second patient resulted in the following values: na results = 128 mmol/l with a data flag and 138 mmol/l on (b)(6)2023.Cl results = 96.3 mmol/l with a data flag, 104.9 mmol/l, and 105.5 mmol/l on(b)(6)2023.The complained sample from the third patient resulted in the following values: ast results = 36.7 u/l and 21.2 u/l on (b)(6)2023.The na, k, and cl electrode lot numbers and expiration dates were requested, but not provided.The ast reagent lot number and expiration date were requested, but not provided.
Additional Manufacturer Narrative
The investigation determined the service actions resolved the issue.

• Brand Name: COBAS 6000 C501 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: 16496361
• Report Number: 1823260-2023-00705
• Device Sequence Number: 6316364
• Product Code: JJE
• UDI-Device Identifier: 04015630916511
• UDI-Public: 04015630916511
• Combination Product (Y/N): N
• Initial Reporter Country: SF
• 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: Foreign,Health Professional,User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 03/17/2023

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: 04745914001
• 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: 02/07/2023
• Supplement Date Received by Manufacturer: 03/14/2023
• Initial Report FDA Received Date: 03/07/2023
• Supplement Report FDA Received Date: 03/17/2023
• 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 Age: 69 YR
• Patient Sex: Female