MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 04,07 report with the FDA on 2010-02-17 for NUTROPIN AQ PEN (SOMATROPIN) SOLUTION FOR INJECTION 10MG manufactured by Genentech, Inc..
[1319564]
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).
Patient Sequence No: 1, Text Type: D, B5
[8517370]
Add'l lot # 784456.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 2917293-2010-00001 |
| MDR Report Key | 1620221 |
| Report Source | 04,07 |
| Date Received | 2010-02-17 |
| Date of Report | 2010-01-15 |
| Date Mfgr Received | 2010-01-15 |
| Date Added to Maude | 2011-04-13 |
| Event Key | 0 |
| Report Source Code | Manufacturer report |
| Manufacturer Link | Y |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 3 |
| Product Problem Flag | 3 |
| Reprocessed and Reused Flag | 0 |
| Health Professional | 0 |
| Initial Report to FDA | 0 |
| Report to FDA | 0 |
| Event Location | 0 |
| Manufacturer Contact | JAMES NICKAS, PHARM.D. |
| Manufacturer Street | 1 DNA WAY |
| Manufacturer City | SOUTH SAN FRANCISCO CA 94080 |
| Manufacturer Country | US |
| Manufacturer Postal | 94080 |
| Manufacturer Phone | 6502255591 |
| Manufacturer G1 | GENENTECH, INC. |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | NUTROPIN AQ PEN (SOMATROPIN) SOLUTION FOR INJECTION 10MG |
| Generic Name | NONE |
| Product Code | KZE |
| Date Received | 2010-02-17 |
| Lot Number | U088 |
| Device Expiration Date | 2011-06-01 |
| Device Age | DA |
| Device Eval'ed by Mfgr | * |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | GENENTECH, INC. |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2010-02-17 |