MAUDE Adverse Event Report: ROCHE DIAGNOSTICS CL ELECTRODE; ELECTRODE, ION-SPECIFIC, CHLORIDE

Catalog Number	03246353001
Medical Device Problem Codes	Incorrect, Inadequate or Imprecise Result or Readings (1535); Low Test Results (2458)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/30/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The c501 module serial number was (b)(6).Calibration was last performed on (b)(6) 2023 and was acceptable.Qc was acceptable.There is no indication of an issue.The centrifugation speed was 5000 revolutions per minute (rpm).This speed may be too fast based on the sample tubes used.The field service engineer (fse) found the cause of the event was aged electrodes.The fse cleaned the electrode compartment, replaced the o-rings in the acrylic blocks, and replaced the electrodes.Calibration, qc, and a 21-cup precision were all acceptable.The service actions resolved the issue.
Event or Problem Description
The initial reporter complained of discrepant results for 1 patient sample tested for cl electrode (cl) and sodium electrode (na) on a cobas 6000 c (501) module.This medwatch will cover cl.Refer to medwatch with a1 patient identifier (b)(6) for information on the na results.The initial cl result was 135 mmol/l.The sample was repeated twice with results of 101 mmol/l and 100 mmol/l.A new sample was obtained and the cl result was 102 mmol/l.The initial na result was 110 mmol/l.The sample was repeated twice with results of 139 mmol/l.A new sample was obtained and the na result was 140 mmol/l.The repeat results were believed to be correct.

• Brand Name: CL ELECTRODE
• Common Device Name: ELECTRODE, ION-SPECIFIC, CHLORIDE
• Manufacturer (Section D): ROCHE DIAGNOSTICS; 9115 hague road; indianapolis IN 46250 0457
• Manufacturer (Section G): ROCHE DIAGNOSTICS GMBH; sandhofer strasse 116; mannheim (baden-wurttemberg) 68305 ; GM 68305
• Manufacturer Contact: amy nelson ; 9115 hague road; indianapolis, IN 46250
• MDR Report Key: 18172862
• Report Number: 1823260-2023-03686
• Device Sequence Number: 7890016
• Product Code: CGZ
• UDI-Device Identifier: 08430215043561
• UDI-Public: 08430215043561
• Combination Product (Y/N): Y
• Initial Reporter State: CT
• 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): N
• Reporter Type: Manufacturer
• Report Source: Health Professional,User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 11/20/2023

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 Catalogue Number: 03246353001
• Device Lot Number: T6479
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 10/30/2023
• Initial Report FDA Received Date: 11/20/2023
• 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