MAUDE Adverse Event Report: ROCHE DIAGNOSTICS ISE SODIUM ELECTRODE; ELECTRODE, ION SPECIFIC, SODIUM

Catalog Number 09237216001

Device Problems Mechanical Problem (1384); Incorrect, Inadequate or Imprecise Result or Readings (1535); Low Test Results (2458)

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

Event Date 01/02/2024

Event Type  malfunction  

Event Description

We received an allegation of questionable ise results for 2 patients' samples tested on a cobas 8000 cobas ise module when compared to a different cobas 8000 cobas ise module.Results for the sodium (na) test were affected: sample 1 (patient 1): initial result: 131 mmol/l.Repeat result: 139 mmol/l.Sample 2 (patient 2): initial result: 127 mmol/l.Repeat result: 137 mmol/l.Qc was within ranges prior to running the patients' samples.The customer then noticed a moving average error prompting the rerun of the samples.The repeat results were deemed to be correct.

Manufacturer Narrative

The na electrode expiration date was not provided.The cobas 8000 cobas ise module serial number was 1982-10.The investigation is ongoing.

Manufacturer Narrative

Sections d1, d2a, d2b, d4, g1 and g4 were updated.The calibration was last performed on (b)(6) and it was acceptable.The alarm trace showed multiple alarms including calibration errors, noise errors, incubator bath water level sensor alarms, and water reservoir level too-low alarms.The fse found that the sample probe was damaged.He replaced the sample probe and performed sample probe adjustments.The fse then performed ise checks and they were successful.Precision studies were performed and they were within specifications.The customer performed qc and it was within the ranges.The cause was due to a damaged sample probe.The service actions (replacing the sample probe and performing sample probe adjustments) resolved the issue.No further issues were reported afterward.

• Brand Name: ISE SODIUM ELECTRODE
• Type of Device: ELECTRODE, ION SPECIFIC, SODIUM
• Manufacturer (Section D): ROCHE DIAGNOSTICS; 9115 hague road; indianapolis IN 46250 0457
• Manufacturer (Section G): HITACHI HIGH TECH CORP.; 882 ichige hitachinaka; ibaraki 312-8 504; JA 312-8504
• Manufacturer Contact: amy nelson ; 9115 hague road; indianapolis, IN 46250-0457
• MDR Report Key: 18553104
• MDR Text Key: 333447404
• Report Number: 1823260-2024-00192
• Device Sequence Number: 1
• Product Code: JGS
• Combination Product (y/n): Y
• Reporter Country Code: US
• PMA/PMN Number: K100853
• 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: 02/23/2024
• 2 Devices were Involved in the Event: 1 2

1 Patient was Involved in the Event

• Date FDA Received: 01/22/2024
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 09237216001
• Device Lot Number: ASKU
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 02/02/2024
• 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
• Patient Age: 3 MO
• Patient Sex: Female