BEUDAMED
    FDA Adverse Event Summary report: N

    NUTROPIN AQ PEN (SOMATROPIN) SOLUTION FOR INJECTION 10MG

    MDR report key: 1620221 · Received February 17, 2010

    Report

    Report Number
    2917293-2010-00001
    Date Received
    February 17, 2010
    Report Date
    January 15, 2010
    Manufacturer
    GENENTECH, INC.
    Product Code
    KZE
    PMA / PMN Number
    20-522
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    ADD'L LOT # 784456.

    Description of Event or Problem · 1

    PEN MALFUNCTIONED WHEN SHE INSERTED A REFILL CARTRIDGE [OVERDOSE]. CASE DESCRIPTION: THIS CASE, (B)(4), IS AN SPONTANEOUS REPORT FROM THE UNITED STATES REFERRING TO A (B)(6), FEMALE, PATIENT. A CONSUMER, WHO IS A RETIRED NURSE, REPORTED THIS CASE. PAST MEDICAL HISTORY INCLUDED "PRE-DIABETIC", BLOOD FOLLICLE STIMULATING HORMONE DECREASED, FIBROMYALGIA, GOUT, AND TOBACCO USER. NEGATIVE MEDICAL HISTORY INCLUDED DRUG HYPERSENSITIVITY. THE PATIENT HAD NO KNOWN DRUG ALLERGIES. NO ALLERGIES OR CONCURRENT ILLNESSES WERE REPORTED. CONCOMITANT MEDICATIONS INCLUDED DIAZEPAM, METHADONE HYDROCHLORIDE, ALLOPURINOL, HYDROCHLOROTHIAZIDE, LISINOPRIL, LEVOTHYROXINE SODIUM, ACETAMINOPHEN, AND HYDROCODONE BITARTRATE. IN (B)(6) 2009, THE PATIENT RECEIVED SOMATROPIN (0.2 MG, QD, SUBCUTANEOUS, LOT NUMBER 784456) VIA NUTROPIN AQ PEN (LOT NUMBER U088) FOR THE INDICATION OF ADULT GROWTH HORMONE DEFICIENCY. THE MOST RECENT DATE OF ADMINISTRATION PRIOR TO THE EVENT WAS (B)(6) 2010. THE PATIENT REPORTED THAT WHEN SHE BEGAN USING NUTROPIN AQ PEN SHE TOOK IT TO HER PHYSICIAN'S OFFICE, AND SHE AND THE NURSE IN THE OFFICE DETERMINED HOW TO USE IT FROM THE PATIENT INSTRUCTIONS PROVIDED IN THE NUTROPIN AQ PEN CARTON. THE OFFICE NURSE AND THE PATIENT HAD NOT SEEN A NUTROPIN AQ PEN PRIOR TO THAT TIME. THE PATIENT DID NOT RECEIVE TRAINING ON THE USE OF THE NUTROPIN AQ PEN VIA THE "TRAINING DVD". ON (B)(6) 2010, THE PATIENT EXPERIENCED NUTROPIN AQ PEN MALFUNCTION WHEN SHE INSERTED A REFILL CARTRIDGE, AND EXPERIENCED SUBSEQUENT OVERDOSE (OVERDOSE). INITIALLY THE REFILL CARTRIDGE HELD 10 MG. THE PATIENT PRIMED THE CARTRIDGE LOSING AN UNSPECIFIED AMOUNT OF MEDICATION. AFTER PRIMING, THE PATIENT INJECTED HER FIRST DOSE WITH THIS CARTRIDGE. AFTER PRIMING AND INJECTION, APPROXIMATELY 5 TO 7 MG OF MEDICATION REMAINED IN THE CARTRIDGE. THE PATIENT REPORTED THAT NUTROPIN AQ PEN DID NOT STOP AS USUAL AFTER SHE STARTED THE INJECTION, BUT KEPT GOING. THE PATIENT REPORTED THAT SHE DID NOT EXPERIENCE ANY SYMPTOMS FOLLOWING THE INJECTION. NO RELEVANT LABORATORY TESTS WERE REPORTED. THE PUNCTURE DATE OF THE VIAL IN QUESTION WAS NOT SPECIFIED. THE TYPE OF STORAGE OF THE PRODUCT WAS NOT REPORTED. IT WAS NOT REPORTED WHETHER THE PATIENT RETAINED THE COMPLAINT VIAL/DEVICE, OR WHETHER IT WAS DISCARDED. ACTION TAKEN WITH SOMATROPIN AND/OR NUTROPIN AQ PEN WAS NOT REPORTED. ON (B)(6) 2010, IN-HOME TRAINING FOR NUTROPIN AQ PEN INJECTION TECHNIQUE WAS OFFERED TO THE PATIENT. THE PATIENT DECLINED THIS OFFER. THE EVENT OUTCOME WAS NOT REPORTED. THE CONSUMER DID NOT REPORT A SPECIFIC CAUSALITY ASSESSMENT OF THE EVENT OVERDOSE AS RELATED TO SOMATROPIN AND/OR NUTROPIN AQ PEN. THE CONSUMER NOTED THAT THE NUTROPIN AQ PEN MAY BE DEFECTIVE. NO OTHER SUSPECT CAUSE WAS REPORTED. NO FURTHER INFORMATION IS EXPECTED. (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 NUTROPIN AQ PEN (SOMATROPIN) SOLUTION FOR INJECTION 10MG NONE KZE GENENTECH, INC. U088

    Patients

    Seq Age Sex Outcome Treatment
    1 59 YR HYDROCODONE/APAP (ACETAMINOPHEN, HYDROCODONE| ALLOPURINOL (ALLOPURINOL)| LEVOTHYROXINE (LEVOTHYROXINE SODIUM)| BITARTRATE)| METHADONE (METHADONE HYDROCHLORIDE)| DIAZEPAM (DIAZEPAM)| LISINOPRIL/HCTZ (HYDROCHLOROTHIAZIDE, LISINOPRIL)