Selling outdated accu-chek test strips
This was computed as the product of the individual probabilities.
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The overall probability of a risk category C event is the aggregate of the probabilities of each of these factors coming true. The prevalence of blood glucose values <70 mg/dl
Selling outdated accu chek test strips code#
These values were then plotted along the consensus error grid ( Figure 3).Įstimated average bias of glucose test strip batches due to a mismatch of the test strip code and the test strip, using four extreme mismatch scenarios at six representative glucose levels.įactors governing the estimated error rates included the probability of:Ī forced mismatch between the test strip code parameters and the test strip, which represents the largest divergence of performance based upon information from 447 glucose test strip batchesĪ customer continuing to use an expired batch of glucose test strips These estimates were calculated by mathematically modeling the influences of the wrong glucose test strip code parameters, the shelf life of test strips, and within-batch variability. The worst-case prediction bias in a mismatch of the glucose test strip code and test strip was estimated for 6 representative glucose levels: 30 mg/dl, 50 mg/dl, 70 mg/dl, 180 mg/dl, 240 mg/dl, and 500 mg/dl. Errors that fall within risk categories A and B have little or no impact on clinical outcome. The greatest concern focuses on errors that fall within risk categories C, D, and E, which all require altered clinical action and are considered extreme events. We analyzed 447 glucose test strip batches manufactured from February 2006 to July 2007, using a consensus error grid according to Parkes et al., 2 with the following risk categories:Īltered clinical action with little or no effect on clinical outcomeĪltered clinical action-likely to affect clinical outcomeĪltered clinical action-could have significant medical riskĪltered clinical action-could have dangerous consequences Historically, coding processes have evolved from printed, changeable color scales that were adaptable to batch-specific conditions, batch-specific code numbers that have to be entered manually into the glucose meter, bar codes that are read by the glucose meter ( Figure 1), to electronic code chips containing the batch-specific code ( Figure 2). In clinical evaluation of a glucose test system, the parameters that are encoded will already have been established and validated. This set of parameters defines the glucose test strip “code”. The second method consists of using the measurements of the quality assurance department to establish a set of parameters that best defines the relationship between the signal change induced on the glucose test strip and the blood glucose concentration. This means the manufacturer of the glucose test strips must adopt strict production tolerances and consequently reject batches of glucose test strips that do not conform to these stringent criteria. In the first method, the production differences are kept so small that their influence on the blood glucose measurement values is not clinically relevant.
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In glucose test strip manufacturing, therefore, the quality assurance department conducts an extensive series of measurements over the entire measurement range of the strip for every batch.īasically, there are two methods for addressing batch-specific differences in the production process of glucose test strips. Within each batch, however, the strip properties remain nearly constant. The numerous raw materials used in the manufacturing process of glucose test strips and the influences to which they are subject can never be held constant-even when the manufacturing conditions are identical-that the same glucose concentration will always elicit the same signal change for every batch.
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This seemingly simple reaction in the test strip is a highly complex process and depends on several factors, including the absorption of the liquid by the reagent layer, the activity of the enzymes, and the sensitivity of the signal-detection method.
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1 Then, the fluid part of the blood containing meter and the blood glucose concentration is calculated the glucose to be measured passes into the reagent layer and presented to the patient. This signal change is evaluated by the glucose of the blood. The reagent layer combines enzymes and blood to a glucose test strip? First, in most glucose test other reagents to elicit a detectable signal change in the strips today, the erythrocytes are separated from the rest test strip. What happens when a patient with diabetes applies of the test strip.