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 Death (1802)

Event Date 12/30/2016

Event Type  Death  

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 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
• 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 07130 ; 7818614364
• MDR Report Key: 6347313
• MDR Text Key: 67892081
• Report Number: 1217183-2017-00001
• Device Sequence Number: 1
• Product Code: CHL
• UDI-Device Identifier: 08426950452591
• UDI-Public: 08426950452591
• Combination Product (y/n): N
• Reporter Country Code: NL
• PMA/PMN Number: K133407
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 02/21/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/21/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: 2261
• Device Catalogue Number: 00025000000
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 01/23/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 07/09/2013
• 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): Death