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 12/14/2023

Event Type  malfunction  

Manufacturer Narrative

The reference electrode expiration date was not provided.The cobas 8000 cobas ise module serial number was (b)(6).The alarm trace showed multiple water reservoir level too low alarms on the day of the event.The field service engineer found an issue with the reference electrode.He replaced the reference electrode.Calibration and qc were performed and they were acceptable.Precision studies were performed and they were within specifications.The cause was due to an issue with the reference electrode.The service action (replacing the reference electrode) resolved the issue.No further issues were reported afterward.

Event Description

We received an allegation of questionable ise results for 2 patients' serum samples tested on a cobas 8000 cobas ise module when compared to a different cobas 8000 cobas ise module.Results for the following tests were affected: sodium (na), and potassium (k).Refer to the attachment for all patients' data.The repeat results were deemed to be correct.

Manufacturer Narrative

The calibration for na and cl showed cal.E alarms on the day of the event.The calibration for k was acceptable with no alarms on the date of the event.D4 catalog number and udi were corrected.

• 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 46250-0457
• MDR Report Key: 18459261
• MDR Text Key: 332272251
• Report Number: 1823260-2024-00065
• 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,Followup
• Report Date: 01/24/2024

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: ASKU
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 12/15/2023
• Initial Date FDA Received: 01/05/2024
• Supplement Dates Manufacturer Received: 01/05/2024
• Supplement Dates FDA Received: 01/24/2024
• 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