MAUDE Adverse Event Report: INSTRUMENTATION LABORATORY GEM PREMIER 5000; CLINICAL CHEMISTRY INSTRUMENT

Model Number	2262
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Death (1802)
Date of Event	06/29/2018
Type of Reportable Event	Death
Additional Manufacturer Narrative
Instrumentation laboratory (il) conducted an investigation that included a review of the data files from the customer's gem premier 5000 instruments.The data review showed that the devices were operating within specifications.There was no system or sensor malfunction during analysis of the patient's samples.For the samples in question, all recoveries were reported as incalculable, except co-ox and its fractions.It should be noted that the results were flagged, including glucose, as "incalculable", which the operator's manual indicates as "required measurement criteria were not met during sample analysis".The investigation concluded that the instruments were operating within specification and, therefore, no remedial action is required.
Event or Problem Description
A complaint was received indicating a death in a patient who developed hypoglycemia following a medication error where insulin was administered instead of heparin because of an incorrectly labeled syringe pump.The complaint states that arterial samples were tested on multiple gem premier 5000 analyzers on (b)(6) 2018.The electrochemical results were not reported and there were no error messages.As a result, the complaint alleges a delay in obtaining glucose results, which if available sooner could have assisted the clinical team with the patient management.

• Brand Name: GEM PREMIER 5000
• Common Device Name: CLINICAL CHEMISTRY INSTRUMENT
• Manufacturer (Section D): INSTRUMENTATION LABORATORY; 180 hartwell road; bedford MA 01730
• MDR Report Key: 7784100
• Report Number: 1217183-2018-00007
• Device Sequence Number: 136273
• Product Code: CHL
• UDI-Device Identifier: 08426950870227
• UDI-Public: 08426950870227
• Combination Product (Y/N): Y
• Initial Reporter Country: GM
• PMA/510(K) Number: K173403
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: health professional
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 08/15/2018

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: Health Professional
• Device Model Number: 2262
• Device Catalogue Number: 00024019255
• Was Device Available for Evaluation?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 08/03/2018
• Initial Report FDA Received Date: 08/15/2018
• 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: Death
• Patient Weight: 75