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

Catalog Number 05110394001

Device Problem Low Test Results (2458)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 12/12/2014

Event Type  malfunction  

Event Description

The customer complained of a questionable ion selective electrode sodium result.The initial result was 90 mmol/l.The repeat result was 123 mmol/l.Information regarding which results were reported outside the laboratory and whether the patient was harmed was requested but not provided.The lot number and expiration date of the sodium electrode were requested but not provided.The field service representative determined the analyzer was not appropriately grounded.After the customer corrected the grounding issue, samples were tested and the results were acceptable.The field service representative determined the analyzer was working properly.

Manufacturer Narrative

The event took place in (b)(6).

Manufacturer Narrative

There were no adverse events.Only the 123 mmol/l result was reported outside the laboratory.

• 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: 4386781
• MDR Text Key: 5429606
• Report Number: 1823260-2015-00058
• 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,Company Representative
• Reporter Occupation: Health Professional
• Type of Report: Initial,Followup
• Report Date: 01/21/2015

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: 05110394001
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Event Location: Laboratory
• Initial Date Manufacturer Received: 12/12/2014
• Initial Date FDA Received: 01/06/2015
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 01/21/2015
• 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