The Food and Drug Administration (FDA) has warned DexCom, maker of blood sugar monitoring equipment that require inserting wires in the abdomen, that it is not adequately warning users that its devices sometimes leave wire splinters under the skin of some users, according to and article in the San Diego Tribune.
The agency also said that Dexcom needs to update the warning labels on its Seven and Seven Plus monitoring systems to indicate the devices have not been approved for use in children, adolescents, patients on dialysis or pregnant women. DexCom’s CEO said the labels already indicate the products should not be used by these groups, but that the company would update the labels to emphasize this point.
The company says it has received 73 complaints about the splinter fragments between January 2008 and March 2009. Last year, one of those incidents required a 30-month old child to go to the emergency room due to an infection in the skin surrounding the broken wire. Another child had to be given anesthesia to remove the wire fragment. The FDA requires firms to report incidents when there is a likelihood they could contribute to death or serious injury.
The FDA’s letter warned of a civil lawsuit if the company does not take steps to remedy the situation within 15 days.
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