NUTROPIN AQ PEN (SOMATROPIN) SOLUTION FOR INJECTION 10MG

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 04,05,07 report with the FDA on 2010-05-21 for NUTROPIN AQ PEN (SOMATROPIN) SOLUTION FOR INJECTION 10MG manufactured by Genentech, Inc..

Event Text Entries

[1610999] 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.
Patient Sequence No: 1, Text Type: D, B5


MAUDE Entry Details

Report Number2917293-2010-00006
MDR Report Key1730142
Report Source04,05,07
Date Received2010-05-21
Date of Report2010-04-21
Date Mfgr Received2010-04-21
Date Added to Maude2010-06-25
Event Key0
Report Source CodeManufacturer report
Manufacturer LinkY
Number of Patients in Event0
Adverse Event Flag3
Product Problem Flag3
Reprocessed and Reused Flag0
Health Professional0
Initial Report to FDA0
Report to FDA3
Event Location0
Manufacturer ContactJAMES NICKAS, PHARM D
Manufacturer Street1 DNA WAY
Manufacturer CitySOUTH SAN FRANCISCO CA 94080
Manufacturer CountryUS
Manufacturer Postal94080
Manufacturer Phone6502255591
Manufacturer G1GENENTECH, INC.
Single Use3
Previous Use Code3
Event Type3
Type of Report3

Device Details

Brand NameNUTROPIN AQ PEN (SOMATROPIN) SOLUTION FOR INJECTION 10MG
Generic NameNONE
Product CodeKZE
Date Received2010-05-21
Lot Number804699
Device AgeDA
Device Eval'ed by Mfgr*
Device Sequence No1
Device Event Key0
ManufacturerGENENTECH, INC.


Patients

Patient NumberTreatmentOutcomeDate
10 2010-05-21

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