Description of Event or Problem · 1
CASE DESCRIPTION: THIS CASE, (B)(4), IS A SPONTANEOUS REPORT FROM (B)(4) REFERRING TO A (B)(6) FEMALE PT. A CONSUMER WHO WAS ALSO A NURSE REPORTED THIS CASE. CONCURRENT CONDITIONS PRESENT AT THE TIME OF THE EVENT INCLUDED HYPOTHYROIDISM. THE PT HAD NO DRUG ALLERGIES. NO PAST MEDICAL HISTORY WAS REPORTED. CONCOMITANT MEDICATIONS INCLUDED LEVOTHYROXINE SODIUM, ZOLPIDEM TARTRATE, DULOXETINE HYDROCHLORIDE AND "AIDECTODIDE." ON (B)(6) 2010, THE PT RECEIVED NUTROPIN AQ, (0.4 MG, QAM, SUBCUTANEOUS) FOR THE INDICATION OF HYPOPITUITARISM. THE LOT NUMBER WAS 804699. THE FIRST PUNCTURE DATE OF LOT NUMBER 804699 WAS NOT REPORTED. THE PT'S PRIOR HISTORY OF EXPOSURE TO LOT NUMBER 804699 WAS NOT REPORTED. ON "(B)(6) 2010", THE PT PRESENTED WITH MAY NOT HAVE BEEN GETTING DOSES FOR 21 DAYS, NOT SEEING THE VOLUME DECREASE IN THE CARTRIDGE (UNDERDOSE). IT WAS REPORTED THAT WHEN THE PT INJECTED A DOSE INTO THE AIR TO TEST IT, NOTHING CAME OUT. RELEVANT LABORATORY TESTS AND TREATMENT WERE NOT REPORTED. IT WAS NOT REPORTED WHETHER THE PT CONTINUED, OR DISCONTINUED, USE WITH LOT NUMBER 804699, AND IT WAS NOT REPORTED WHETHER THE PT SWITCHED TO ANOTHER LOT NUMBER. ACTION TAKEN WITH NUTROPIN AQ WAS NOT REPORTED. THE EVENT OUTCOME WAS UNK. THE CONSUMER DID NOT PROVIDE AN ASSESSMENT FOR THE EVENT UNDERDOSE IN RELATION TO NUTROPIN AQ. IN THE RPTR'S OPINION, OTHER POSSIBLE ETIOLOGICAL FACTORS INCLUDED A FAULTY PEN AND/OR CARTRIDGE. THIS REPORT WAS FORWARDED TO GENENTECH PRODUCT QUALITY. THE PCS NUMBER WAS PENDING. ADDITIONAL INFO IS BEING REQUESTED. IF RECEIVED, THE CASE WILL BE UPDATED ACCORDINGLY. PHARMACOVIGILANCE: UNDERDOSE IS UNLABELED IN THE USPI. NON-SERIOUS CASE FOR PRODUCT QUALITY REVIEW.