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 04/19/2023

Event Type  malfunction  

Manufacturer Narrative

The customer exchanged the electrodes.The field service engineer cleaned the valves and changed the vacuum valves.He cleaned the ise area, cleaned the ise bath, cleaned the probes, and checked the adjustments.He performed multiple ise checks without issues.Calibration and qc were within specifications.The investigation is ongoing.

Event Description

There was an allegation of questionable ise indirect gen 2 sodium results from the cobas 6000 c501 module.The samples were repeated as there were multiple critical results.Patient 1 initial result was 118 mmol/l and the repeat result was 137 mmol/l.Patient 2 initial result was 118 mmol/l and the repeat result was 129 mmol/l.Patient 3 initial result was 117 mmol/l and the repeat result was 139 mmol/l.Patient 4 initial result was 130 mmol/l and the repeat result was 137 mmol/l.The questionable results were reported outside of the laboratory.The repeat results were believed correct.The sodium electrode lot number was c02 with an expiration date of 25-jun-20223.

Manufacturer Narrative

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; sandhoferstrasse 116; na; mannheim (baden-wurttemberg) 68305 ; GM 68305
• Manufacturer Contact: amy nelson ; 9115 hague road; na; indianapolis, IN 46250 ; 3174767531
• MDR Report Key: 16886306
• MDR Text Key: 314740407
• Report Number: 1823260-2023-01533
• Device Sequence Number: 1
• Product Code: CEM
• Combination Product (y/n): N
• 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: 07/17/2023

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 Expiration Date: 07/25/2023
• Device Catalogue Number: 03149501001
• Device Lot Number: Y58
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 04/19/2023
• Initial Date FDA Received: 05/08/2023
• Supplement Dates Manufacturer Received: 07/03/2023
• Supplement Dates FDA Received: 07/17/2023
• 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