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

Model Number ISE 9180

Device Problem Incorrect Or Inadequate Test Results (2456)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 01/23/2017

Event Type  malfunction  

Manufacturer Narrative

(b)(4).This event occurred in (b)(6).

Event Description

The customer received questionable ise indirect na, k, ci for gen.2 sodium results for an unknown number of patient samples.Specific data was requested but was not provided.Information concerning if any erroneous result was reported outside the laboratory was requested, but it was unknown.There was no adverse event.The electrode lot number and expiration date were requested but were not provided.

Manufacturer Narrative

Additional information was provided that the erroneous results were not reported outside the laboratory.The electrode was cleaned and qc was performed which was in range.

Manufacturer Narrative

Information was provided that the sodium result from the roche analyzer was "130 mmol" and the result from another laboratory was "138 mmol".The sodium electrode lot number was 21562347.Result printouts could not be provided nor the na electrode that was used in the alleged measurements.No further information or data was available for this complaint.Trending on the lot number of the na electrode showed no other complaints.The certificate of analysis of this electrode batch showed no indication for the complained issue.Based on the information provided, no issue could be found with the analyzer.The customer was using biorad qc material which is not approved for use on this analyzer.Product labeling states that the use of consumables that were not produced by roche, including but not limited to electrodes, calibration and cleaning solutions, qc-material, and related accessories may result in malfunction of the analyzer and may lead to incorrect patient results.

• Brand Name: ISE 9180
• Type of Device: BLOOD GAS ANALYZER
• Manufacturer (Section D): ROCHE DIAGNOSTICS; 9115 hague road; indianapolis IN 46250 0457
• 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: 6336174
• MDR Text Key: 67814799
• Report Number: 1823260-2017-00351
• 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,u
• Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date: 03/21/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/16/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: ISE 9180
• Device Catalogue Number: 03157334001
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 01/23/2017
• 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
• Type of Device Usage: N
• Patient Sequence Number: 1