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

Model Number	2261
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Therapeutic Response, Increased (2272)
Date of Event	02/01/2018
Type of Reportable Event	Serious Injury
Additional 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 or Problem 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
• Common Device Name: CLINICAL CHEMISTRY INSTRUMENT
• Manufacturer (Section D): INSTRUMENTATION LABORATORY CO.; 180 hartwell rd; bedford MA 01730
• MDR Report Key: 7361605
• Report Number: 1217183-2018-00002
• Device Sequence Number: 16186330
• Product Code: CHL
• UDI-Device Identifier: 08426950452591
• UDI-Public: 08426950452591
• Combination Product (Y/N): N
• Initial Reporter State: CT
• Initial Reporter Country: US
• PMA/510(K) Number: K133407
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Health Professional
• Type of Report: Initial
• Report Date (Section B): 03/22/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: No Information
• Device Model Number: 2261
• Device Catalogue Number: 00025000000
• Was Device Available for Evaluation?: Yes
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/20/2018
• Initial Report FDA Received Date: 03/22/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other