Description of Event or Problem · 1
THIS CASE REPORTED BY A CONSUMER (PATIENT'S SPOUSE) CONCERNS A PATIENT WHO EXPERIENCED HYPERGLYCEMIA. THE PATIENT WAS TAKING INSULIN ISOPHANE SUSPENSION-HUMULIN/UMULINE NPH CARTRIDGES VIA A PEN INJECTOR DEVICE (HUMAPEN ERGO, MS8930) AND USING BD MICROFINE +8 MM NEEDLES FOR TREATMENT OF DIABETES MELLITUS. THE PATIENT WAS A TRAINED USER BUT IT IS UNKNOWN HOW LONG PATIENT USED A PEN INJECTOR DEVICE (HUMAPEN ERGO). THE PATIENT'S MEDICAL HISTORY INCLUDED: DIABETES MELLITUS FOR 56 YEARS. CONCOMITANT MEDICATIONS WERE NOT PROVIDED. IN 2002, DURING THERAPY WITH HUMAN INSULIN ISOPHANE SUSPENSION (HUMULIN/UMULINE NPH, SUBCUTANEOUS, DOSAGE UNKNOWN, CARTRIDGE 3 ML) VIA A PEN INJECTOR DEVICE (HUMAPEN ERGO, MS8930), THE PATIENT EXPERIENCED FOR THE FIRST TIME HYPERGLYCEMIA (FASTING GLYCEMIA AT 4 G/L). THE NEXT 2 DAYS, TWO OTHER EPISODES OF HYPERGLYCEMIA RECCURRED FOLLOWING INJECTION OF INSULIN ISOPHANE SUSPENSION. THE PATIENT'S PEN INJECTOR DEVICE (HUMAPEN ERGO, MS8930) PLUNGER WAS BLOCKED AND THEREFORE THE DOSE WAS NOT CORRECTLY DELIEVERED. THE DEVICE IS BEING RETURNED TO THE MANUFACTURER (LILLY) FOR ANALYSIS. THE ANALYSIS RESULTS ARE PENDING. IT IS UNKNOWN WHETHER THE SUSPECT DRUG WAS CONTINUED. THE DEVICE WAS DISCONTINUED. THE EVENT OUTCOME WAS UNKNOWN. THE ASSESSMENT OF THE REPORTER'S RELATEDNESS WAS NOT STATED AS THE REPORTER WAS A NON HEALTHCARE PROFESSIONAL.