MAUDE Adverse Event Report: ROCHE DIAGNOSTICS REFERENCE ELECTRODE

Catalog Number 03149501001

Device Problem Low Test Results (2458)

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

Event Date 03/08/2024

Event Type  malfunction  

Event Description

There was an allegation of calibration and qc issues and questionable ise indirect gen 2 sodium results from the cobas 8000 cobas ise module.Patient 1 initial result was 134 mmol/l and the repeat result was 146 mmol/l.Patient 2 initial result was 131 mmol/l and the repeat result was 141 mmol/l.Patient 3 initial result was 131 mmol/l and the repeat result was 140 mmol/l.Patient 4 initial result was 134 mmol/l and the repeat result was 142 mmol/l.Patient 5 initial result was 134 mmol/l and the repeat result was 143 mmol/l.The repeat results were believed to be correct.

Manufacturer Narrative

The cobas 8000 cobas ise module serial number was (b)(6).The sodium electrode lot number was p60.The expiration date was not provided.The field service engineer found the ise bath housing was contaminated.The customer removed the electrodes and found a buildup along the bottom of the electrodes.The electrodes were replaced, the housing was cleaned, and the pinch tube was replaced.The investigation determined the service actions resolved the issue.

• Brand Name: REFERENCE ELECTRODE
• Type of Device: REFERENCE ELECTRODE
• 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: 18990146
• MDR Text Key: 338886872
• Report Number: 1823260-2024-00929
• Device Sequence Number: 1
• Product Code: CEM
• 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: 03/27/2024

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: 03149501001
• Device Lot Number: G95
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 03/11/2024
• Initial Date FDA Received: 03/28/2024
• Was Device Evaluated by Manufacturer?: Yes
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Age: 60 YR