[1270192]
Not sure if received over dose or did not receive the right amount, cartridge and pen issues [medication error]. Case description: this case , manufacturer control number (b)(4), is an spontaneous report from the (b)(6) referring to a female patient (age not reported). A consumer who is a nurse reported this case. No past medical history, concurrent illnesses, or allergies were reported. There were no concomitant medications reported. On a date not reported, the patient initiated nutropin aq, ("dose alternates between 02. Mg and 0. 4mg", frequency not reported, route not reported) via nutropin aq pen for the indication of growth hormone deficiency. The lot number was 745892. The lot number for nutropin aq pen was b121. The first puncture date of lot number 745892 was on (b)(6) 2009. The patient's prior history of exposure to lot number 745892 was not applicable. The most recent date of administration prior to the event was also on (b)(6) 2009. On the same day, (b)(6) 2009, the patient was not sure if received over dose or did not receive the right amount, cartridge and pen issues (medication error). The patient reported that on (b)(6) 2009, she dialed 0. 2mg and approximately 12 mg was dispensed. This was the first injection from the cartridge. The patient reported that she did prime the cartridge in the pen prior to the dose. She also reported that it took several tries to prime the cartridge, but the usual amount of fluid was expelled. She reported that she was not sure if she even received the complete dose or she may have been overdosed. The patient reported that she had changed the cartridge twice before with no problems. Relevant laboratory tests and treatment were not reported. It was reported, if the patient continued or discontinued treatment with lot number 745892. It was not reported if the patient switched to another lot number. The action taken with nutropin aq was not reported. It was reported that the patient would continue taking nutropin aq. The outcome of the event was not reported. The consumer did not assess the event medication error in relation to nutropin aq. No possible etiological factors were reported. The report was forwarded to genentech product quality and assigned pcs# (b)(4). Additional information is being requested. If received, the case will be updated accordingly.
Patient Sequence No: 1, Text Type: D, B5