This case involving a device reported by a consumer who contacted the company as both their devices broken down. The patient's medical history was not provided and it was unknown if the patient was taking any concomitant medications. The patient was taking human regular insulin (humulin r) 10-14-8 iu a day and human insulin isophane suspension (humulin n) 17 iu a day for the treatment of insulin dependent diabetes mellitus (iddm) beginning on an unknown date. In 07/2003, an unknown duration after beginning humulin n and humulin r via humapen ergo, the patient was hospitalized with a hyperglycemic coma, with a blood glucose of 30. Both humapen ergos broke down on the same day, one pen was unsuable and the other pen sometimes injected the correct dose. Their physician gave them a prescription for a new pen, and as they were unable to obtain the new pen they had to continue using the broken pen. It was unknown what corrective treatment the patient received for the hyperglycemic coma. The patient was discharged seven days later. The device were operated by the patient trained for an unknown duration. The return of the devices is anticipated. Final analysis by pds found the complaint device was tested and met the performance specifications. During the investigation the observation was made that the device was slightly difficult to dial and the injection screw was slightly difficult to advance/retract, however the device performance specifications remained within specification and it was determined that this slight difficulty was secondary to foreign material contamination. The analysis also found cartridge holder one engagement tab broken, cartridge holder one engagement tab carcked, cartridge holder both spring arms cracked, these defects do not impact performance specifications on this pen. There is evidence of improper use/storge: needle reused - possible underdose; did not prime the device - possible underdose; did not hold for five seconds - possible underdose. There is no assessment on causality as the reporter is not a health care professional. Update 09/2003: additional information received via affiliate in 08/2003 and esi on 08/2003, added final analysis to narrative and device fields and changed event from hypoglycemia to hyperglycaemia. Relevant tests: ni.

Upon return of the device, an evaluation will be performed to determine if a malfunction has occurred. No report is planned unless the device is returned and found to have a reportable malfunction/near incident. This report concerns the device that has not yet returned.