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

Catalog Number 03246353001

Device Problem Low Test Results (2458)

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

Event Date 06/23/2023

Event Type  malfunction  

Manufacturer Narrative

No electrode lot numbers with expiration dates were provided.The field service engineer (fse) found a pinched rinse tube.The customer ran qc, but the results were out of range.The fse performed instrument testing indicating all assays were within specification.The customer replaced the internal standard (is) reagent bottle, recalibrated, and ran qc.Qc was acceptable after replacing the is bottle.No issues were identified during a review of the alarm trace data.The service maintenance actions resolved the issue.

Event Description

The initial reporter complained of discrepant results for 2 patient samples tested for sodium (na) and chloride (cl) on a cobas 6000 c (501) module.This medwatch will cover cl.Refer to medwatch with a1 patient identifier pt-83076 for information on the na results.Patient 1 initial na result was 120 mmol/l.The repeat result was 133 mmol/l.Patient 2 initial na result was 122 mmol/l.The repeat result was 132 mmol/l.Patient 2 initial cl result was 87.6 mmol/l.The repeat result was 97.1 mmol/l.The repeat results were believed to be correct.

• 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: 17515303
• MDR Text Key: 321722872
• Report Number: 1823260-2023-02608
• 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
• Report Date: 08/11/2023

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
• Device Operator: Health Professional
• Device Catalogue Number: 03246353001
• Device Lot Number: ASKU
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 07/25/2023
• Initial Date FDA Received: 08/11/2023
• 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
• Patient Age: 49 YR
• Patient Sex: Male