PERIODIC THE DEBATE:
The Spanish Agency for Medicines and Health Products (AEMPS) has reported a possible failure in a series of insulin bombs in our country.The person in charge of notifying him has been the manufacturer himself, Tandem Diabetes Care, who has sent an incidence to the health dependent body.Thus, he noted that the speakers of these bombs, designed for LJA Subcutaneous insulin administration in the control of diabetes mellitus, have a higher failure rate.
Specifically, the tools that have failed are insulin bombs T: Slim X2, so it advises users to always have an alternative.
As the company explains in a statement, when the current measurements that pass through the speaker during use are outside the expected range, an alarm of malfunction is activated (‘Failure code 16’), at which time the insulin administration stops, the pump stops working and communication with the continuous glucose monitoring device is interrupted.
Which could cause an episode of hyperglycemia, which in the most serious cases may require urgent hospitalization or medical care, he adds.
Therefore, the AEMPS advises the users of these bombs that, even if this failure is not presented, continue using their pump normally, but taking the necessary precautions, since it could occur at any time.
In the case of experiencing it, No Novalab's technical service must be notified and changed to the alternative method of insulin administration according to the doctor's instructions, which he advises to always have prepared, in addition to regularly controlling the blood sugar level to ensure that he does not present unexpectedly high or low readings.
On the other hand, the AEMPS has issued a second notice in which it informs of a quality defect of several 20 %Lipoplus lots, an emulsion of water oils that provide energy and contain essential fatty acids necessary to patients who need to be fed by intravenous dripping, since they are not able to ingest food normally or their intake is not sufficient.
Lipoplus is indicated in adults, premature newborn infants, term newborn infants, infants and young children, children and adolescents.
Laboratory B. Braun Medical has communicated the detection of agglomerates in some lots of this medicine that can be developed throughout the period of validity of the drug.
To avoid risks derived from the presence of these agglomerates, the AEMSP indicates that the medicine should be administered with a perfusion filter for lipid emulsions;Lacking this, the product should not be administered when the remaining expiration is less than 12 months.
The centers that have units of the affected lots with expiration less than the year and cannot guarantee the use of adequate perfusion filters in the administration of the medication must proceed to their return.
