This device case, reported by nurse, with further info from a second nurse, concerns a pt who experienced high blood glucose levels and was hospitalized. The pt was using a pen injection device (humapen ergo) to deliver 20% soluble insulin/80% isophane insulin (humalog m2) for the treatment of type ii diabetes mellitus. The pt had started using the pen injection device one week prior to the report. The pt presented at the clinic feeling unwell on the day of the event. On examination it was found the pts blood glucose level was 39. 9mmol/l and the pt was admitted to hosp by the consultant physician. The pt was still in hosp three days later. The reporter stated that when the plunger of the pen was depressed, the rod that pushes down the bung on the insulin cartridge was only working intermittently. The pt has not yet recovered. The events are unassessed by a heatlth professional. Further info has been requested. The pen is to be returned. Update 08/21/2001: further info rec'd from a second nurse. Pt info, therapy info and device info. Update 08/22/2001: preliminary comments received from pharmaceutical delivery system (pds) on 08/21/2001. Preliminary report prepared.

The manufacturer (pharmaceutical delivery systems) has not received the device associated with this complaint. When the device is received, the manufacturer will perform an investigation to determine if the device is functioning correctly.

Results and conclusions received from pharmaceutical delivery systems (pds).

Results/conclusions: the rptr stated that when the plunger of the pen was depressed, the rod that pushes down the bung on the insulin cartridge was only working intermittently. However, the complaint device was not returned for investigation. Therefore, the mfr cannot confirm or conclude that the reported event was caused by a device breakage or a device malfunction. Further investigation is not planned unless the complaint device is returned to the mfr.