In the events reported to FDA, practitioners misinterpreted the results on the glucometers when the blood glucose was displayed using an out-of-range abbreviation, such as RR LO (out of reportable range low limit) or CR LO (out of critical range low limit), and/or when numeric alarm codes (e.g., W-510) were displayed in a pop-up message. These events involved mistakes in interpreting patients’ blood glucose levels due to the way the results were displayed on some glucometer screens, including ACCU-CHEK Inform (no longer available from the manufacturer) and ACCU-CHEK Inform II (Roche Diagnostics), a commonly used POC glucometer by the VHA. The study was conducted in response to multiple adverse events reported to the US Food and Drug Administration (FDA) since 2010. In a more recent study conducted by the Veterans Health Administration (VHA), 8 a different type of error was described.

3 Other factors that can affect POC glucose test results include hematocrit, ascorbic acid levels, 4 and other sugars such as maltose, 5 including maltose-containing medications or parenteral solutions.

3 In the latter case, a study in a neonatal unit showed that staff failed to confirm two patient identifiers for 45% of the POC tests performed. For example, earlier studies have found that the most common types of errors associated with POC glucose testing are related to delays in testing due to the unavailability of trained staff 2 and a failure to positively identify patients prior to testing. 1 While POC glucose testing offers immediate results that can be used to make important clinical decisions about the treatment of hypo- or hyperglycemia, errors can occur at any point in the testing process. Problem: Glucose testing is one of the most frequent point-of-care (POC) tests performed in hospitals.

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