Description of Event or Problem · 1
(B)(6) YEAR DM2 OLD PATIENT D/C FROM LOCAL HOSPITAL (B)(6) 2018 ON INSULIN PENS AND COMMON BRAND SHORT PEN NEEDLES. PEN NEEDLES WERE SUBSTITUTED BY OUR FACILITY WITH GENERIC DROPLET PEN NEEDLES 29G, 12MM (MFG. HTL STREFA) PATIENT USED THE BRAND NAME PEN NEEDLES HE WAS ORIGINALLY GIVEN INSTEAD OF GENERIC SUBSTITUTE. PATIENT HAD EXCELLENT DM CONTROL, WITH FASTING AM BLOOD SUGARS BETWEEN 80/120. HE THEN WANTED TO BE SUPPLIED WITH BN PEN NEEDLES THROUGH OUR FACILITY. HE WAS INSTEAD SWITCHED TO GENERIC DROPLET PEN NEEDLES 31G, 8MM (MFG. HTL STREFA). THE DAY AFTER STARTING THEN PEN NEEDLES, HIS FASTING SUGAR WAS 266 UP FROM 133 THE DAY BEFORE. EVERY DAY SINCE THEN HIS SUGARS HAVE RANGED FROM 250-365 FASTING WHEN THEY WERE WELL CONTROLLED BEFORE. PATIENT HAS CALLED THE CLINIC TEAM AT HIS LOCAL CLINIC WHERE PCP IS SEVERAL TIMES AND HAS COME IN 2-3 TIMES IN THE LAST 2 MONTHS TO SEE PCP OR THE NURSE ABOUT THE HIGH SUGARS AND THEY HAVE ADVISED HIM TO LEAVE THE NEEDLE IN THE SKIN LONGER AND THE OTHER ADAPTIVE MEASURES. HE HAS TRIED THESE MEASURES AND STILL HIS SUGARS ARE OUT OF CONTROL. IN ADDITION, HE RELATES THAT NO MATTER HOW LONG HE LEAVES THE NEEDLE IN, THERE IS STILL INSULIN DRIPPING FROM THE NEEDLE WHEN HE PULLS IT OUT OF THE SKIN. THERE HAVE BEEN SEVERAL OTHER PATIENT COMPLAINTS REGARDING THIS BRAND OF PEN NEEDLES. SYMPTOMS: SYMPTOMS: 1 HYPERGLYCEMIA. NEEDLE DOSE: 1 UNIT: UNITS FREQ: HS ROUTE: SQ.