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.
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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.
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