MAUDE Adverse Event Report: INSTRUMENTATION LABORATORY CO. GEM PREMIER 4000; CLINICAL CHEMISTRY INSTRUMENT

Model Number 2261

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Therapeutic Response, Increased (2272)

Event Date 02/01/2018

Event Type  Injury  

Manufacturer Narrative

Instrumentation laboratory (il) conducted an investigation that included a review of the data files from the customer's gem premier 4000.The data review showed that the device was operating within specifications.There was no system or sensor malfunction during analysis of the patient's sample.Although the patient's sodium intake was increased (dosage not known), there was no perceived impact to the patient.We are submitting this mdr due to the location (nicu) of the patient.No remedial action is required.

Event Description

Customer reported that due to a sodium value of 128 mmol/l on gem premier 4000 located in the nicu, the patient's sodium intake was increased.However, when the lab analyzer reported a sodium value of 150 ten hours later, the gem premier 4000 sodium result was questioned.There was no perceived impact to the patient due to the increased sodium intake.

• Brand Name: GEM PREMIER 4000
• Type of Device: CLINICAL CHEMISTRY INSTRUMENT
• Manufacturer (Section D): INSTRUMENTATION LABORATORY CO.; 180 hartwell rd; bedford MA 01730
• Manufacturer (Section G): INSTRUMENTATION LABORATORY CO.; 180 hartwell rd; bedford MA 01730
• Manufacturer Contact: shari o'connor ; 180 hartwell rd; bedford, MA 01730 ; 7818614364
• MDR Report Key: 7361605
• MDR Text Key: 103170085
• Report Number: 1217183-2018-00002
• Device Sequence Number: 1
• Product Code: CHL
• UDI-Device Identifier: 08426950452591
• UDI-Public: 08426950452591
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K133407
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Health Professional
• Type of Report: Initial
• Report Date: 03/22/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/22/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: No Information
• Device Model Number: 2261
• Device Catalogue Number: 00025000000
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 02/20/2018
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 08/04/2017
• 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
• Patient Outcome(s): Other