Description of Event or Problem · 0
IT WAS REPORTED THAT THE USER EXPERIENCED UNEXPECTED HYPERGLYCEMIA WHILE USING THE CONTACT DETACH INFUSION SET (23 INCH, 6 MM; LOT 6013996), WITH GLUCOSE AROUND 220 MG/DL FOR A FEW HOURS, AFTER WHICH THE HEALTHCARE PROVIDER ADVISED REPLACING ALL SUPPLIES; BLOOD GLUCOSE RETURNED TO RANGE FOLLOWING THE CHANGE. SYMPTOMS INCLUDED THIRST, DIZZINESS, AND NAUSEA. OUTCOMES INCLUDED THE NEED TO REPLACE INFUSION SUPPLIES EARLIER THAN PLANNED. INVESTIGATION INCLUDED TROUBLESHOOTING AND USER EDUCATION. INVESTIGATION OF THIS CASE REVEALED NO OBSERVED INFUSION SET ABNORMALITIES SUCH AS LEAKS, BUBBLES, OR KINKS, AND THE CAUSE OF THE HYPERGLYCEMIA REMAINED UNCLEAR. IT WAS CONCLUDED, BASED ON PREVIOUSLY ESTABLISHED FINDINGS FOR SIMILAR REPORTS, THAT THE CAUSE WAS INCONCLUSIVE. IF THE DEVICE IS RETURNED, A PHYSICAL EVALUATION WILL BE PERFORMED, AND A SUPPLEMENTAL WILL BE SUBMITTED.