Description of Event or Problem · 1
THIS CASE, REPORTED BY A CONSUMER WITH AN ADD'L CASE REPORTED BY THE CONSUMER, WHO CONTACTED THE COMPANY WITH A PRODUCT COMPLAINT AND ADVERSE EVENT, CONCERNS A PT. THE PT'S MEDICAL HISTORY WAS NOT PROVIDED. THE PT TOOK SEVEN UNSPECIFIED TYPES OF SLEEPING MEDICATION. THE PT WAS TAKING HUMAN INSULIN ISOPHANE SUSPENSION (HUMULIN N, 44 UNITS, FOR AN UNKNOWN DURATION), VIA A HUMAPEN ERGO TEAL/OPAQUE PEN, FOR THE TREATMENT OF DIABETES. IT WAS REPORTED THAT THE HUMULIN N CARTRIDGE (LOT # FF3M54B) DID NOT MIX WELL. THE PT WAS ALSO TAKING INSULIN LISPRO (HUMALOG 2 TIMES 27 UNITS, DURATION UNKNOWN) VIA ANOTHER HUMAPEN ERGO TEAL/OPAQUE PEN (LOT # UNKNOWN), FOR AN UNSPECIFIED INDICATION. ON AN UNKNOWN DATE THE PT EXPERIENCED BLOOD SUGAR OF 17 (MMOL/LITRE), IT IS NORMALLY AROUND 6 TO 8 (MMOL/LITRE). IT WAS REPORTED THAT THE TWO PENS WERE NOT WORKING. ONE PEN, RECEIVED IN 2003 DID NOT EVEN DIAL AND THE DIALING KNOB WAS STUCK. THIS HUMULIN N COMPLAINT IS ASSOCIATED WITH CID00209042. THE 2 HUMAPEN ERGO TEAL/OPAQUE PENS (LOT # UNKNOWN) WERE OPERATED BY THE PT WHO WAS A TRAINED USER. THE PT USED THE FIRST PEN FOR HUMULIN N, USING NOVOFINE (30 GAUGE, 6 MM) NEEDLE TIPS. THE DEVICE AGE WAS 2 WEEKS AND THE PT STORED THE DEVICE IN THE FRIDGE. THE AGE, DURATION OF USE AND STORAGE OF THE SECOND HUMAPEN TEAL/OPAQUE WERE NOT REPORTED. THE COMPLAINT FOR THE FIRST HUMAPEN ERGO TEAL/OPAQUE PEN IS ASSOCIATED WITH CID0020937. THE DEVICES AND CARTRIDGES WERE TO BE RETURNED TO THE PHARMACY. THE PT CONTINUED TO USE HUMULIN N (40 UNITS AT BEDTIME) AND HUMALOG (20 UNITS IN THE MORNING AND 20 UNITS AT SUPPER TIME) FOR THE TREATMENT OF DIABETES. THE PT ADMINISTERED THE HUMULIN N AND HUMALOG VIA TWO PEN INJECTOR DEVICES (HUMAPEN ERGO BURGUNDY/CLEAR, LOT#40245 AND HUMAPEN ERGO TEAL/CLEAR, LOT #40249). THE PT NOTICED A PROBLEM WITH REGARDS TO THEIR BLOOD SUGARS ONE TO TWO WEEKS AGO IN 2003. THE PT NOTICED THAT THEY DID NOT FEEL VERY GOOD AND THEY WERE DIZZY. THE PT WAS HOSPITALIZED OVERNIGHT AND WAS ADMINISTERED NITRO SPRAY. THE PT DID NOT KNOW THE SPECIFIC DATE OF THEIR HOSPITAL STAY. THE PT'S BLOOD SUGARS WERE REGISTERING BETWEEN 12.8 AND 14.7 (MMOL/LITRE) (NORMAL = 6-8 MMOL/LITRE). THE PT WAS KEPT OVERNIGHT FOR OBSERVATION. THE PT RETURNED BOTH PRODUCTS (HUMULIN N AND HUMALOG). NO ADD'L INFO COULD BE SUPPLIED REGARDING LOT NUMBERS AND EXPIRY DATES. THE PT ALWAYS PRIMED THEIR PENS AND HAD RECENTLY NOTICED A PROBLEM WITH THE PENS STICKING. THE PT INJECTED INTO THEIR LEGS AND BELLY. PT OUTCOME IS NOT KNOWN. IT IS NOT KNOWN IF THE PT CONTINUES TO USE HUMULIN N AND HUMALOG. THE PT OPERATED BOTH DEVICES AND WAS A TRAINED USER. BOTH DEVICES WERE TWO YEARS OLD AND USED FOR TWO YEARS. THE PT USED BD ULTRA-FINE III (31 GAUGE, 8 MM) NEEDLE TIPS AND STORED THE DEVICES AT ROOM TEMPERATURE. THIS HUMAPEN ERGO BURGUNDY/CLEAR COMPLAINT IS ASSOCIATED WITH CID00214731. THIS HUMAPEN ERGO TEAL/CLEAR COMPLAINT IS ASSOCIATED WITH CID00214944. BOTH DEVICES WERE RETURNED TO THE COMPANY THE FOLLOWING MONTH. BOTH DEVICES HAVE BEEN SENT TO THE MFR (PHARMACEUTICAL DELIVERY SYSTEMS) FOR FURTHER ANALYSIS. FURTHER INFO IS BEING REQUESTED.