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 02,04 report with the FDA on 2009-08-31 for NUTROPIN AQ PEN (SOMATROPIN) SOLUTION FOR INJECTION 10MG manufactured by Genentech, Inc..

Event Text Entries

[15703140] Overdose [overdose]. Case description: this case, (b)(4), is a solicited report from the united states referring to an (b)(6) male patient. A consumer reported the event from a genentech sponsored patient support program for somatropin. No past medical history, concurrent illnesses, allergies or concomitant medications were reported. On a date not reported, the patient received somatropin (2. 8 mg, qd, subcutaneous) using a somatropin pen for an unspecified indication. The lot number was not reported. The last dose administered prior to the onset of the event was not reported. The first puncture date of the product in question and the patient's history of exposure to the product lot number in question were not reported. On (b)(6) 2009, the patient experienced an overdose (overdose). Relevant laboratory tests and treatments for the event were not reported. On (b)(6) 2009, the patient "just figured out why his medication supply was running out early". The patient noted that he had been using the somatropin aq 20 mg cartridges in the 10 mg aq pen. The patient stated that he "just realized this" and switched to the appropriate 20 mg pen. It was not reported if the patient continued use with the product lot number in question and if the patient switched to another lot number. It was further noted that he thought this had occurred over the past 5 months. The patient made no comment regarding any side effects of this error but was advised to call his physician. Action taken with somatropin was not reported. The patient discontinued use with somatropin 10 mg pen. At the time of this report, the event outcome was not reported. The event was identified as medically significant by the reporter. The consumer did not provide an assessment for the event of overdose in relation to somatropin and somatropin pen. No other possible etiological factors were reported. This report was forwarded to genentech product support and assigned (b)(4). Additional information is being requested. If received, the case will be updated accordingly. Pharmacovigilance: overdose is labeled in the (b)(4) for somatropin for an unspecified indication. Based on the temporal relationship between the onset of the event and administration of somatropin, a causal association cannot be excluded. The patient did not realize that he was using a 20 mg cartridge in a 10 mg pen.
Patient Sequence No: 1, Text Type: D, B5


MAUDE Entry Details

Report Number2917293-2009-00005
MDR Report Key1458857
Report Source02,04
Date Received2009-08-31
Date of Report2009-08-06
Date Mfgr Received2009-08-06
Date Added to Maude2011-03-28
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 FDA0
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 Received2009-08-31
Lot NumberNOT REPORTED
Device AgeDA
Device Eval'ed by Mfgr*
Device Sequence No1
Device Event Key0
ManufacturerGENENTECH, INC.


Patients

Patient NumberTreatmentOutcomeDate
101. Other 2009-08-31

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