Description of Event or Problem · 1
ON (B)(6) 2011, PT REPORTED THAT SHE HAS EXPERIENCED ERRATIC BLOOD GLUCOSE OVER THE PAST 2-3 MONTHS AND THAT SHE BELIEVES THE INSULIN DELIVERY OF THE INFUSION DEVICE IS INACCURATE. PT PROVIDED AN EXAMPLE FROM (B)(6) 2011. BLOOD GLUCOSE WAS 193 MG/DL IN THE EVENING. PT DID NOT EAT DINNER AND DELIVERED 2.5 UNITS OF INSULIN THROUGH THE INFUSION DEVICE. PT WOKE ON THE MORNING OF (B)(6) 2011 WITH A BLOOD GLUCOSE OF 270 MG/DL. SHE CHANGED THE COMPETITOR'S INFUSION SET AND DELIVERED AN INSULIN INJECTION. SHE ATE LUNCH AND DELIVERED A BOLUS THROUGH THE INFUSION DEVICE, AND BLOOD GLUCOSE WAS 462 MG/DL 2 HOURS LATER. AT 11:15 P.M., BLOOD GLUCOSE WAS 142 MG/DL. SHE DELIVERED 0.5 UNITS THROUGH THE INFUSION DEVICE, AND BLOOD GLUCOSE DECREASED TO 52 MG/DL AT 3:25 A.M. ON (B)(6) 2011. PT ATE CARBOHYDRATES TO TREAT HYPOGLYCEMIA. BLOOD GLUCOSE WAS THEN 292 MG/DL WHEN SHE WOKE LATER IN THE MORNING. SHE RECEIVED AN E4 OCCLUSION ERROR ON (B)(6) 2011 AND CHANGED THE COMPETITOR'S INFUSION SET TO CLEAR IT. THERE HAS BEEN NO INSULIN POOLING AT INFUSION SITES. INFUSION DEVICE, CARTRIDGE, AND ADAPTER WERE REPLACED AND REQUESTED FOR EVAL. THE PT DID NOT REQUIRE TREATMENT FROM A HEALTH CARE PROFESSIONAL OR SECOND PARTY TO ADDRESS THE ISSUE. ADD'L ATTEMPTS WERE MADE TO FOLLOW-UP WITH PT, AND THESE WERE UNSUCCESSFUL.