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

Model Number 2262

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

Patient Problem Death (1802)

Event Date 06/29/2018

Event Type  Death  

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 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
• Type of Device: CLINICAL CHEMISTRY INSTRUMENT
• Manufacturer (Section D): INSTRUMENTATION LABORATORY; 180 hartwell road; bedford MA 01730
• Manufacturer (Section G): INSTRUMENTATION LABORATORY; 180 hartwell road; bedford MA 01730
• Manufacturer Contact: susan conte ; 180 hartwell road; bedford, MA 01730
• MDR Report Key: 7784076
• MDR Text Key: 117124797
• Report Number: 1217183-2018-00006
• Device Sequence Number: 1
• Product Code: CHL
• UDI-Device Identifier: 08426950870227
• UDI-Public: 08426950870227
• Combination Product (y/n): Y
• Reporter Country Code: GM
• PMA/PMN Number: K173403
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 08/15/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/15/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: 2262
• Device Catalogue Number: 00024019255
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 08/03/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Death
• Patient Age: 94 YR
• Patient Weight: 75