[18512124]
Overdose, headache, pain at injection site [accidental overdose]. Case description: this case, (b)(4), is a solicited report from (b)(6) referring to a (b)(6) female patient. The patient's father reported the event from a company sponsored patient support program for nutropin aq. No past medical history, concurrent illnesses, or allergies were reported. There were no concomitant medications reported. On (b)(6) 2010, the patient initiated nutropin aq (0. 7 mg, frequency not reported, subcutaneous, lot number not reported) via nutropin aq pen (lot number u061) for an unknown indication. This was the only dose prior to the event onset. On the same day, (b)(6) 2010, the patient experienced overdose, headache, pain at injection site (overdose accidental). The patient's father reported that he set the injector to administer 0. 7 mg nutropin aq on the evening of (b)(6) 2010. He stated that the nutropin aq pen malfunctioned and the patient received 3. 5 mg. He reported that he was unable to return the piston to the center of the injector. Relevant laboratory tests and treatment were not reported. There was no action taken with nutropin aq or nutropin aq pen. On the same day, (b)(6) 2010, the event resolved. On (b)(6) 2010, the patient complained of headache and pain at injection site. The patient was given motrin to treat the headache, which resolved the same day. The pain at injection site was reported as persisting. The consumer did not provide a causality assessment of the event overdose accidental in relation to nutropin aq or nutropin aq pen. The consumer noted that the nutropin aq pen malfunctioned. There were no possible etiological factors reported. Additional information is being requested. If received, the case will be updated accordingly.
Patient Sequence No: 1, Text Type: D, B5