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	Death (1802)
Date of Event	12/30/2016
Type of Reportable Event	Death
Additional Manufacturer Narrative
Instrumentation laboratory (il) conducted an investigation that included a review of data files from the customer's gem premier 4000.The data review showed that the device was operating within the specifications.There was no system or sensor malfunction during analysis of the patient's samples.The customer stated that there was no correlation of this patient's death to gem premier 4000 instrument performance.Therefore, no remedial action is required at this time.
Event or Problem Description
A customer requested instrumentation laboratory (il) to review two glucose recoveries from a gem premier 4000 instrument.Both samples were from the same patient.The samples were analyzed on (b)(6) 2016.The first sample analyzed at 12:56 produced an incalculable glucose result.The second sample analyzed at 13:37 produced a glucose result of >41.6 mmol/l.Il was informed that the patient died later.

• 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: 6347313
• Report Number: 1217183-2017-00001
• Device Sequence Number: 977030
• Product Code: CHL
• UDI-Device Identifier: 08426950452591
• UDI-Public: 08426950452591
• Combination Product (Y/N): N
• Initial Reporter Country: NL
• PMA/510(K) Number: K133407
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: foreign
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 02/21/2017

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?: No
• Operator of Device: Health Professional
• Device Model Number: 2261
• Device Catalogue Number: 00025000000
• Was Device Available for Evaluation?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/23/2017
• Initial Report FDA Received Date: 02/21/2017
• 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: Death