MAUDE Adverse Event Report: INSTRUMENTATION LABORATORY COMPANY GEM PREMIER 4000; ELECTRODE MEASUREMENT, BLOOD-GASES (PCO2, PO2) AND BLOOD PH

Device Problem Device Displays Incorrect Message (2591)

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

Event Date 08/28/2017

Event Type  malfunction  

Event Description

This error was on an abg blood gas machine (gem 4000).The cartridge installed showed an error in the analysis of o2 and was expelled by the machine automatically.This was a 150 sample cartridge where 54 samples were used.Information on the cartridge in question is; reference # 00027415004, lot 720500016/181496309.This error has been called into instrumentation laboratory and we have received a case number.

• Brand Name: GEM PREMIER 4000
• Type of Device: ELECTRODE MEASUREMENT, BLOOD-GASES (PCO2, PO2) AND BLOOD PH
• Manufacturer (Section D): INSTRUMENTATION LABORATORY COMPANY; 180 hartwell dr.; bedford MA 01730
• MDR Report Key: 6904292
• MDR Text Key: 87773568
• Report Number: 6904292
• Device Sequence Number: 1
• Product Code: CHL
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: Biomedical Engineer
• Type of Report: Initial
• Report Date: 08/28/2017

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: No Information
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 08/28/2017
• Device Age: 8 YR
• Event Location: Hospital
• Date Report to Manufacturer: 08/28/2017
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 09/29/2017
• Type of Device Usage: N
• Patient Sequence Number: 1