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 2009-07-01 for NUTROPIN AQ PEN (SOMATROPIN) SOLUTION FOR INJECTION 10MG manufactured by Genentech, Inc..

Event Text Entries

[1270192] Not sure if received over dose or did not receive the right amount, cartridge and pen issues [medication error]. Case description: this case , manufacturer control number (b)(4), is an spontaneous report from the (b)(6) referring to a female patient (age not reported). A consumer who is a nurse reported this case. No past medical history, concurrent illnesses, or allergies were reported. There were no concomitant medications reported. On a date not reported, the patient initiated nutropin aq, ("dose alternates between 02. Mg and 0. 4mg", frequency not reported, route not reported) via nutropin aq pen for the indication of growth hormone deficiency. The lot number was 745892. The lot number for nutropin aq pen was b121. The first puncture date of lot number 745892 was on (b)(6) 2009. The patient's prior history of exposure to lot number 745892 was not applicable. The most recent date of administration prior to the event was also on (b)(6) 2009. On the same day, (b)(6) 2009, the patient was not sure if received over dose or did not receive the right amount, cartridge and pen issues (medication error). The patient reported that on (b)(6) 2009, she dialed 0. 2mg and approximately 12 mg was dispensed. This was the first injection from the cartridge. The patient reported that she did prime the cartridge in the pen prior to the dose. She also reported that it took several tries to prime the cartridge, but the usual amount of fluid was expelled. She reported that she was not sure if she even received the complete dose or she may have been overdosed. The patient reported that she had changed the cartridge twice before with no problems. Relevant laboratory tests and treatment were not reported. It was reported, if the patient continued or discontinued treatment with lot number 745892. It was not reported if the patient switched to another lot number. The action taken with nutropin aq was not reported. It was reported that the patient would continue taking nutropin aq. The outcome of the event was not reported. The consumer did not assess the event medication error in relation to nutropin aq. No possible etiological factors were reported. The report was forwarded to genentech product quality and assigned pcs# (b)(4). Additional information is being requested. If received, the case will be updated accordingly.
Patient Sequence No: 1, Text Type: D, B5


MAUDE Entry Details

Report Number2917293-2009-00004
MDR Report Key1409839
Report Source04,05,07
Date Received2009-07-01
Date of Report2009-06-02
Date Mfgr Received2009-06-02
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 Received2009-07-01
Lot NumberB121
Device AgeDA
Device Eval'ed by Mfgr*
Device Sequence No1
Device Event Key0
ManufacturerGENENTECH, INC.


Patients

Patient NumberTreatmentOutcomeDate
10 2009-07-01

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