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

Catalog Number 03246353001

Device Problems High Test Results (2457); Non Reproducible Results (4029)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 10/19/2023

Event Type  malfunction  

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 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.

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
• Type of Device: 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
• MDR Text Key: 328076880
• Report Number: 1823260-2023-03606
• Device Sequence Number: 1
• Product Code: CGZ
• UDI-Device Identifier: 08430215043561
• UDI-Public: 08430215043561
• Combination Product (y/n): Y
• Reporter Country Code: US
• PMA/PMN Number: K060373
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,User Facility
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 11/22/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/14/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 03246353001
• Device Lot Number: P9545
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 11/17/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1