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

Catalog Number 10825468001

Device Problems High Test Results (2457); Calibration Problem (2890); Non Reproducible Results (4029)

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

Event Date 06/01/2023

Event Type  malfunction  

Event Description

There was an allegation of questionable gen.2 ise indirect for na results for 2 patient samples on a cobas 6000 c (501) module.The initial results were reported outside of the laboratory.The results were questioned and the samples were repeated.For patient 1, the initial na result was 168 mmol/l.The repeat result was 142 mmol/l.For patient 2, the initial na result was 162 mmol/l.The repeat result was 132 mmol/l.The repeat results were deemed correct.

Manufacturer Narrative

The customer's qc was acceptable.The customer performed calibration after the questionable results were produced and received a calibration error.The investigation is ongoing.H3 other text : na.

Manufacturer Narrative

The field service engineer (fse) found a solenoid valve was malfunctioning and was causing insufficient cleaning of the cuvette cells.The fse also found a hole in the vacuum tubing, the fse replaced the valve and the tubing, ran ise checks, and performed calibration and qc successfully.The service maintenance actions performed by the fse resolved the issue.No further issues were reported after the service visit.

• Brand Name: NA ELECTRODE
• Type of Device: ELECTRODE, ION SPECIFIC, SODIUM
• 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: 17227546
• MDR Text Key: 318376484
• Report Number: 1823260-2023-02121
• Device Sequence Number: 1
• Product Code: JGS
• UDI-Device Identifier: 08430215011546
• UDI-Public: 08430215011546
• 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: 07/21/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/29/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 10825468001
• Device Lot Number: P8043
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 06/29/2023
• 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