[1016477]
Used wrong cartridge and received double the normal dose. [accidental overdose]. Case description: this case, (b)(4) is a spontaneous report from the united states referring to a (b)(6) male patient. A physician reported this case. No past medical history, allergies, or concurrent conditions were reported. Concomitant medications included "conciron". On a unspecified date, the patient started treatment with nutropin aq (2. 4 mg, qd, subcutaneous) with the nutropin aq pen (dose, frequency and route not reported) for the indication of growth hormone deficiency. The lot numbers for nutropin aq and nutropin qa pen were not reported. The first puncture dates of the unknown lot numbers were not reported. The patient's prior history of exposure to the unknown lot numbers was not reported. On an unspecified date in "(b)(6)-2008", the patient used the wrong cartridge and received double the normal dose (accidental overdose). The patient's mother ordered the 20 mg nutropin aq pen but was only sent the 20 mg cartridges of nutropin aq. So the mother used the 20 mg cartridge fit into the 10 mg pen. On 26-aug-2008, the pharmacy notified the mother that she was reordering too soon and it was discovered that she was using the cartridge in the incorrect pen. The mother was uncertain as to how many cartridges were used in the wrong pen but guessed "may be 3". Treatment for the event was not reported. No adverse events were noted. The patient's mother reported that the "pen was leaking and clicking more than usual so he may not have received the full dose". Action taken with nutropin aq was not reported. It was not reported whether the patient switched to another lot number of nutropin aq, however, the patient switched from the 10 mg pen to 20 mg pen. On (b)(6)-2008, the event was reported as resolved. On (b)(6)-2008, relevant laboratory tests included igf 775 mg/ml and igf-bp-3- 6. 6mg/l. It was reported that igf levels were unchanged and were the same as prior to the event. The physician did not provide a casuality assessment of the event accidental overdose in relation to nutropin aq and nutropin aq pen. No other possible etiological factors were identified. This report was forwarded to genentech, inc. Product quality (b)(4). Additional follow up is being requested. If received, the case will be updated accordingly.
Patient Sequence No: 1, Text Type: D, B5