Themes, Rates, and Risk of Adverse Events of the Artificial Pancreas in the United States Using MAUDE.

Three manufacturers sell artificial pancreas systems in the United States for management of Type 1 Diabetes. Given the life-saving task required of an artificial pancreas there needs to be a high level of trust and safety in the devices. This evaluation sought to find the adjusted safety event reporting rate and themes along with device-associated risk in events reported utilizing the MAUDE database. We searched device names in the MAUDE database over the period from 2016 until August 2023 (the date of retrieval). Thematic analysis was performed using dual-reviewer examination with a 96% concurrence. Relative risk (RR) was calculated for injury, malfunction, and overall, for each manufacturer, as well as adjusted event rate per manufacturer. Most events reported related to defects in the manufacturing of the casing materials which resulted in non-delivery of therapy. Tandem Diabetes Care, Inc. had an adjusted event rate of 50 per 100,000 units and RR of 0.0225. Insulet had an adjusted event rate of 300 per 100,000 units and RR of 0.1684. Medtronic has an adjusted event rate of 2771.43 per 100,000 units and RR of 20.7857. The newer Medtronic devices show improvements in likely event rate. While the artificial pancreas is still in its infancy, these event rates are not at an acceptable level for a device which can precipitate death from malfunctions. Further exploration into safety events and much more research and development is needed for devices to reduce the event rates. Improved manufacturing practices, especially the casing materials, are highly recommended. The artificial pancreas holds promise for millions but must be improved before it becomes a true life-saving device that it has the potential to become.

Thyroid neoplasia associated with nutritional deficiency in cultured jade perch in Hong Kong.

Non-neoplastic thyroid hyperplasia is common in terrestrial animals, secondary to nutritional imbalances or other goitrogenic compounds. Thyroid hyperplasia is relatively common in teleost fish; however, malignant thyroid neoplasia is rarely reported. We diagnosed cases of thyroid neoplasia in a population of jade perch (Scortum barcoo). The 3,000 affected fish had grossly apparent, bilateral pharyngeal swellings. Histologic examination confirmed proliferative thyroid lesions ranging from hyperplasia to well-differentiated follicular cell carcinoma. In addition, the younger population of animals on the farm also had bacterial septicemia and mild Dactylogyrus sp. gill infections. Feed analysis revealed a severe deficiency of iodine and vitamin C in the homemade fish diet used on the farm. The concentrations of other minerals, such as zinc, were also on the lower end of the recommended requirements for freshwater fish. The farm was using surface water in its recirculating aquaculture system. We recommended a switch to a commercial aquaculture diet, as well as to use well water rather than surface water to avoid any contaminants, and to treat the younger fish with an antibiotic for bacterial septicemia. Our case provides evidence of progression from nutritional-associated thyroid hyperplasia to neoplasia in farmed teleost fish.

The Effects of the COVID-19 Pandemic on Penetrating Neurotrauma at a Level 1 Trauma Center.

BACKGROUND/OBJECTIVE: The COVID-19 pandemic has had a profound impact on the global delivery of health care. Recent data suggest a possible impact of the pandemic on patterns of neurotrauma. The aim was to assess the impact of the pandemic on the incidence of neurotrauma, with a focus on cranial gunshot wounds (cGSWs) at a large Midwestern level 1 trauma center. METHODS: We conducted a retrospective review of our trauma registry from March through September 2020 and compared it to the same months in 2019. Odds ratios were utilized to assess for differences in patient demographics, injury characteristics, rates of neurotrauma, and rates of cGSWs. RESULTS: A total of 1188 patients presented with neurotrauma, 558 in 2019 and 630 in 2020. The majority of patients were male (71.33% in 2019; 68.57% in 2020) and Caucasian (78.67% in 2019; 75.4% in 2020). Patients presented with cGSWs more frequently in 2020 (n = 49, 7.78%) than in 2019 (n = 25, 4.48%). The odds of suffering a cGSW in 2020 was 73.6% higher than those in 2019 (95% confidence interval = [1.0871, 2.7722]; P = 0.0209). The etiology of such injury was most commonly assault (n = 16, 21.62% in 2019; n = 34, 45.95% in 2020), followed by self-inflicted injury (n = 4, 5.41% in 2019; 12, 16.22% in 2020). CONCLUSIONS: Despite the government-mandated shutdown, we observed an increase in the number of neurotrauma cases in 2020. There was a significant increase in the incidence cGSWs in 2020, with an increase in assaults and self-inflicted injuries. Further investigation into socioeconomic factors for the observed increase in cGSWs is warranted.