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

Catalog Number 03157334001

Device Problem Incorrect Or Inadequate Test Results (2456)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 04/20/2015

Event Type  malfunction  

Event Description

The customer reported that they received questionable results for an unknown number of patient samples tested for ion selective electrode (ise) tests.Data was provided for one patient sample and for this sample, there were erroneous ise sodium and ise potassium results.The sample initially resulted as 115 mmol/l for ise sodium and 5.9 mmol/l for ise potassium.The physical condition of the patient did not match the initial results, so the sample was repeated.The sample was repeated on a cobas b221 analyzer, resulting as 148.4 mmol/l accompanied by a data flag for ise sodium and 4.34 mmol/l for ise potassium.The patient was not adversely affected.The ise sodium electrode lot number was 306270.The ise potassium electrode lot number was 298689.The electrode expiration dates were asked for, but not provided.The sample probe,fill port, and electrode contact pins of the analyzer were cleaned.Maintenance and calibrations were also performed on the instrument.Results were said to be comparable after these actions were completed.No further result data was provided.

Manufacturer Narrative

This event occurred in (b)(6).

Manufacturer Narrative

A specific root cause could not be determined.Investigations did determine that the customer did not run quality control material to check the instrument performance.Product labeling recommends routine use of quality controls.

• 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: 4746531
• MDR Text Key: 5709834
• Report Number: 1823260-2015-03408
• 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
• Report Date: 05/19/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/04/2015
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Nurse
• Device Catalogue Number: 03157334001
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Event Location: Laboratory
• Date Manufacturer Received: 04/20/2015
• 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