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

Catalog Number	03246353001
Medical Device Problem Codes	High Test Results (2457); Non Reproducible Results (4029)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/19/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The cobas pro ise analyzer serial number was (b)(6).The field service engineer (fse) found no issues.A precision check was performed.The customer had deproteinized the electrodes.The customer ran successful calibration and qc.The investigation is ongoing.
Event or Problem Description
The initial reporter complained of discrepant results for 3 patient samples tested for cl electrode (cl) and na electrode (na) on a cobas pro ise analytical unit.This medwatch will cover cl.Refer to medwatch with a1 patient identifier (b)(6) for information on the na results.Patient 1: the initial na result was 157 mmol/l.The repeat result was 140.7 mmol/l.The initial cl result was 114 mmol/l.The repeat result was 102.3 mmol/l.Patient 2: the initial na result was 161 mmol/l.The repeat result was 143.2 mmol/l.The initial cl result was 118 mmol/l.The repeat result was 104.2 mmol/l.Patient 3: the initial na result was 167 mmol/l.The repeat result was 157.2 mmol/l.The initial cl result was 136 mmol/l.The repeat result was 122.6 mmol/l.The customer noticed the initial results did not match the patient¿s previous history and repeated the samples on a different analyzer.The repeat results were believed to be correct.
Additional Manufacturer Narrative
Multiple calibrations were performed on (b)(6) 2023 and (b)(6) 2023 with acceptable results.The customer stated qc was acceptable prior to the event.The samples were spun down for 5 minutes at 3600 revolutions per minute (rpm).Based on the sample tubes used, this spin time is shorter than recommended.Although no cause was found, the instrument performance was verified and the issue appears to be resolved.The investigation did not identify a product problem.The cause of the event could not be determined.

• 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: 18133648
• Report Number: 1823260-2023-03606
• Device Sequence Number: 18090256
• Product Code: CGZ
• UDI-Device Identifier: 08430215043561
• UDI-Public: 08430215043561
• Combination Product (Y/N): Y
• Initial Reporter State: TX
• 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): 11/22/2023

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: P9545
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 10/19/2023
• Supplement Date Received by Manufacturer: 11/17/2023
• Initial Report FDA Received Date: 11/14/2023
• Supplement Report FDA Received Date: 11/22/2023
• 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