Description of Event or Problem · 1
THE PT WAS TAKING LISPRO (HUMALOG) 6IU IN THE MORNING, 8IU IN THE AFTERNOON AND 6IU IN THE EVENING. LISPRO WAS RECEIVED VIA HUMAPEN ERGO BURGUNDY WITH A CLEAR CARTRIDGE HOLDER (A26539). THEY WERE ALSO TAKING HUMAN LENTE INSULIN RDNA (HUMULIN L) 14IU A DAY BEFORE GOING TO BED. HUMULIN L WAS RECEIVED VIA HUMAPEN ERGO TEAL WITH A CLEAR CARTRIDGE HOLDER. BOTH INSULINS WERE TAKEN FOR THE TREATMENT OF DIABETES AND BOTH BEGAN DURING 2002 WITHOUT EXPERIENCING ANY PROBLEMS. THE PT LOST THEIR HUMAPEN MS8929 AND BOUGHT A NEW PEN FROM THE PHARMACY. IN 2003, THEY EXPERIENCED HYPERGLYCEMIA. INITIALLY THEY HAD NO PROBLEMS WITH HYPERGLYCEMIA. THE PT SAW THEIR DIABETOLOGIST, WHO ADJUSTED THE DOSE OF INSULIN. THEIR HYPERLYCAEMIA GOT WORSE (BLOOD GLUCOSE LEVELS INCREASED TO 300-400) AND THEY EXPERIENCED A DIABETIC COMA. THE PT RETURNED THE DEVICE (MS8930, LOT Z26539 & CID 00185738) TO THE PHARMACY AND ASKED FOR A NEW PEN. THEY EXPLAINED TO THE CHEMIST THAT THEIR HYPERGLYCAEMIA HAD NOT IMPROVED. THE CHEMIST CHECKED THE PEN AND SAW THAT THE UNITS DISPENSED BY THE PEN WERE NOT THE EXPECTED UNITS. THIS WAS DUE TO THE PISTON NOT WORKING PROPERLY. THE EVENTS RESOLVED AND THE PT MAD A FULL RECOVERY. THEY ARE STILL USING THE SAME LISPRO CARTRIDGE WHICH THEY WERE USING WITH THE DEVICE IN QUESTION WITHOUT ANY PROBLEMS. THERAPY WITH LISPRO AND HUMILN L WERE STILL CONTINUING. THE DEVICE WAS OPERATED BY THE PT AND THEY WERE A TRAINED USER. THEY CHANGED THE NEEDLE EACH TIME BUT NEVER PERFORMED THE PRIMING BEFORE ADMINISTERING THE INSULIN. THE PT HAD STARTED USING THIS TYPE OF DEVICE IN 2002. THEY STARTED USING THE DEVICE IN QUESTION SOMETIME IN 2003. THE RETURN OF THE DEVICE WAS ANTICIPATED. DEVICE WAS NOT CONTINUED. FOLLOW UP FOR INVESTIGATION RESULTS IN PENDING. THE CHEMIST COULDN'T EXCLUDE THAT THE EVENTS WERE RELATED TO THE USE OF THE DEVICE, BUT WERE NOT RELATED TO LISPRO AND HUMULIN L.