DH notified of recall of specific lots of MiniMed Infusion Sets


Hong Kong (HKSAR) -      The Department of Health (DH) today (September 12) received notification from medical device manufacturer Medtronic Hong Kong Medical Limited (Medtronic) on its voluntary recall of specific lots of MiniMed Infusion Sets due to a potential safety concern.
 
     According to the information provided by Medtronic, the MiniMed Infusion Sets are used with Medtronic insulin pumps. Medtronic has recently received reports of potential over-delivery of insulin after changing of infusion set.
 
     The manufacturer's investigation revealed that the problem could be caused by fluid blocking the infusion set membrane during the priming/fill-tubing process. A membrane blocked by fluid most likely occurs if insulin, alcohol, or water is spilled on the top of the insulin reservoir which can then prevent the infusion set from working properly.
 
     The manufacturer said that new infusion sets currently being shipped contain an enhanced membrane material that can significantly reduce the risk concerned.
 
     While patients with new and enhanced infusion sets that are not part of the recall can continue to use their sets, those who are using the infusion sets being recalled should carefully follow the key steps regarding the priming/fill-tubing process as advised by the manufacturer before they can obtain new sets. 
 
     "Over-delivery of insulin can cause hypoglycemia and in extreme cases, death.

We noted that the manufacturer has received relevant reports of hypoglycemia requiring medical intervention overseas. So far, the DH has not received any reports of adverse incidents related to the affected lots of infusion sets in Hong Kong," a spokesman for the DH said.
 
     Patients using the affected devices should visit the manufacturer's website (https://checklots.medtronicdiabetes.com/" target="_blank">checklots.medtronicdiabetes.com) to check if the infusion sets they are using are being recalled. The manufacturer will arrange for replacement of affected devices.
 
     According to the local supplier, the concerned lots were supplied to 169 patients and 5 clinics/medical centres.

The supplier will contact the healthcare professionals and patients concerned to recall the unused sets. It has also set up a hotline (2919 6441) for customer enquiries.
 
     "We will alert public and private hospitals as well as relevant medical associations to the recall and replacement exercise, and will liaise with the local supplier on the follow-up actions," the spokesman added.
 
     "Members of the public should consult healthcare professionals if in doubt or feeling unwell after using their medical devices," the spokesman said.



Published on: 2017-09-12

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