Description of Event or Problem · 1
FIFTY50 INSULIN PUMP SYRINGE 1.8 ML RESERVOIRS COMPATIBLE WITH MINIMED PARADIGM PUMPS. (B)(4) AND LOT 75922. I USED RESERVOIRS FROM 3 DIFFERENT BOXES THAT I RECEIVED AND ALL APPEAR TO BE DANGEROUSLY DEFECTIVE. THE LUER LOCK DOES NOT TIGHTEN DOWN, ALLOWING INSULIN TO LEAK OUT DURING A BOLUS. THIS MEANS THE PATIENT IS NOT RECEIVING A FULL DOSE OF INSULIN DURING A BOLUS. THIS WAS CONFIRMED BY STICKING THE CORNER OF A TISSUE INTO AN AREA THAT SHOULD HAVE BEEN DRY. THE ISSUE CAME OUT WET AND SMELLED OF INSULIN. THE LOOSE LUER LOCK ALSO PULLS STRAIGHT OFF OF THE RESERVOIR IF IT CATCHES ON SOMETHING E.G. A HAND OR AN ARM. UNLESS THE PATIENT NOTICES THAT THE TUBING HAS BECOME DISCONNECTED, THE PATIENT WILL BE WITHOUT ANY INSULIN UNTIL THE TUBING IS RECONNECTED. THE LUER LOCK FILLS WITH INSULIN AND ALLOWS BUBBLES TO ENTER DURING THE PRIMING PROCESS. THE BUBBLES GET INTO THE TUBING, WHICH LEAVES THE PATIENT RECEIVING NO INSULIN FOR SOMETIMES LONG PERIODS OF TIME. EACH TIME I USED THESE RESERVOIRS, I HAD BLOOD SUGAR READINGS THAT WERE CHRONICALLY IN THE HIGH 200S TO HIGH 300S AND WOULD NOT COME DOWN. I COULD NOT FIGURE OUT WHY FOR SEVERAL DAYS. THIS IS DANGEROUS AND COULD LEAD TO HOSPITALIZATION. ROUTE: SQ. DATES OF USE: (B)(6) 2010. DIAGNOSIS OR REASON FOR USE: DIABETES MELLITUS TYPE 1. EVENT ABATED AFTER USE STOPPED OR DOSE REDUCED?: YES. EVENT REAPPEARED AFTER REINTRODUCTION?: YES.