MAUDE Adverse Event Report: ROCHE DIAGNOSTICS ISE 9180; BLOOD GAS ANALYZER

Catalog Number 03107019001

Device Problem Low Test Results (2458)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 05/20/2014

Event Type  malfunction  

Manufacturer Narrative

Manufacturing site name was updated.

Manufacturer Narrative

A definitive root cause could not be determined.It noted the customer did not run quality control prior to testing the samples.It was noted the sodium and potassium had been on board the analyzer for over a year and were passed their on board times.Quality control verification by the customer should have informed them of the state of the electrodes.

Manufacturer Narrative

The customer provided data for three patients with questionable ion selective electrode potassium results, of which two had discrepant results that were reported outside the laboratory.The samples were tested on (b)(6) 2014.The samples were repeated on another 9180 analyzer.The first patient's initial potassium result was 7.35 mmol/l.The repeat result was 8.2 mmol/l.The second patient's initial potassium result was 4.5 mmol/l.The repeat result was 5.0 mmol/l.Information on whether the patients were adversely affected was requested but not provided.The potassium electrode lot number was 21522761.The expiration date was requested but not provided.

Event Description

The customer alleged they received very low ion selective electrode sodium and potassium results on their ise 9180 analyzer.The customer provided data for one discrepant sodium result that was reported outside the laboratory.The patient's initial sodium result was 95 mmol/l.The repeat result was 109 mmol/l.The patient was not adversely affected by this event.The sodium electrode lot number was requested but not provided.The field service representative checked and cleaned the electrodes, needle, and wash port.He tested the electrodes and found variations.He performed calibration.He ran samples and found variations in the sodium and potassium results.It was noted the customer was not performing quality control on the analyzer to check the performance of the system.

Manufacturer Narrative

This event occurred in (b)(6).

Manufacturer Narrative

Additional information has been provided.The sodium electrode lot number was 21522955.

• Brand Name: ISE 9180
• Type of Device: BLOOD GAS ANALYZER
• Manufacturer (Section D): ROCHE DIAGNOSTICS; 9115 hague road; indianapolis IN 46250
• Manufacturer (Section G): ROCHE INSTRUMENT CENTER AG TEGIMENTA; forrenstrasse; na; rotkreuz 6343 ; SZ 6343
• Manufacturer Contact: michael leslie ; 9115 hague road; na; indianapolis, IN 46250 ; 3175214343
• MDR Report Key: 3849117
• MDR Text Key: 11975816
• Report Number: 1823260-2014-04013
• Device Sequence Number: 1
• Product Code: JFP
• Combination Product (y/n): N
• Reporter Country Code: IN
• PMA/PMN Number: K961458
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,User Facility
• Reporter Occupation: Health Professional
• Type of Report: Initial,Followup,Followup,Followup,Followup
• Report Date: 08/08/2014

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: 03107019001
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Event Location: Laboratory
• Initial Date Manufacturer Received: 05/20/2014
• Initial Date FDA Received: 06/04/2014
• Supplement Dates Manufacturer Received: Not provided; Not provided; Not provided; Not provided
• Supplement Dates FDA Received: 06/24/2014; 07/21/2014; 07/31/2014; 08/08/2014
• 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: 044 YR
• Patient Weight: 52