MAUDE Adverse Event Report: ROCHE DIAGNOSTICS K ELECTRODE; ELECTRODE, ION SPECIFIC, POTASSIUM

Catalog Number ASKU

Device Problems Incorrect Measurement (1383); Incorrect, Inadequate or Imprecise Result or Readings (1535); Low Test Results (2458)

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

Event Date 01/23/2024

Event Type  malfunction  

Manufacturer Narrative

The serial number of the c501 analyzer is (b)(6).The customer noted that the issue is still occurring.The investigation is ongoing.

Event Description

The initial reporter stated they received discrepant ise results for 8 patient samples tested on a cobas 6000 c (501) module.Results for the following parameters are affected: na electrode, k electrode, and cl electrode.This medwatch will apply to the k electrode.Please refer to the medwatch with a1.Patient identifier (b)(6) for information related to the na electrode and refer to the medwatch with a1.Patient identifier (b)(6) for information related to the cl electrode.Refer to the attachment for all patient data.All results in the "repeat 1" column, except for sample 2, were automatically repeats performed on the complained analyzer.Results in the "repeat 2" column were measured on a second analyzer.Discrepancies were first found for samples 1 and 2.No questionable results from these samples were reported outside of the laboratory.The samples were repeated and the repeat values were deemed correct.The customer performed maintenance on the analyzer, but this did not resolve the issue.The customer then reported they had result discrepancies for samples 3-8.

Manufacturer Narrative

For all samples, no questionable results were reported outside of the laboratory and the repeat values were deemed correct.One level of control was outside of range for sodium.One level of control was also outside of range for all ise tests.The sample centrifugation time may have been shorter and the speed may have been higher than recommended by the tube manufacturer.The field service engineer found an issue with a probe slider.The slider was replaced.An issue was also found with some valves.The valves were replaced and the ise units were cleaned.The engineer ran activator on the ise system.The customer ran controls and these passed.No further issues occurred after these actions.The investigation determined the service actions resolved the issue.Medwatch fields d1, d2, d4, g1, and g4 have been updated.

• Brand Name: K ELECTRODE
• Type of Device: ELECTRODE, ION SPECIFIC, POTASSIUM
• 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: 18796305
• MDR Text Key: 336437742
• Report Number: 1823260-2024-00568
• 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: 03/11/2024
• 2 Devices were Involved in the Event: 1 2

1 Patient was Involved in the Event

• Date FDA Received: 02/28/2024
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: ASKU
• Device Lot Number: V4861
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 03/04/2024
• 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