MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 04 report with the FDA on 2009-11-09 for NUTROPIN AQ PEN (SOMATROPIN) SOLUTION FOR INJECTION 10 MG manufactured by Genentech, Inc..
[1252619]
Consistently getting more doses per cartridge than they should when using nutropin aq 20 pen [medication error]. Case description: this case, mfr control number (b)(4), is a spontaneous report from the united states referring to a male pt of unk age. The pt's mother reported this case. No past medical history, concomitant medications, allergies, or concurrent conditions were reported. On an unspecified date reported as six months ago, the pt started treatment with nutropin aq (1. 6 mg, frequency and route not reported) and nutropin aq pen (dose, frequency and route not reported) for an unk indication. The nutropin aq lot number was not reported. The nutropin aq pen lot number was reported as b105. The first puncture date of the b105 was not reported. This was the pt's first pen. It was not reported whether the pt continued or discontinued use with lot number b105. It was not reported whether the pt switched to another lot number. On an unspecified date, the pt presented with consistently getting more doses per cartridge than they should when using nutropin aq 20 pen (medication error). It was reported that the pt received 13-15 doses per 20 mg cartridge instead of 12. 5 doses. Relevant lab tests, treatment for the event and action take with nutropin aq and nutropin aq pen were not reported. The mother was to send the nutropin aq pen to genentech, inc. The event outcome was not reported. The consumer did not provide an assessment of the event medication error in relation to nutropin aq and nutropin aq pen. No other possible etiological factors were identified. This report was forwarded to genentech, inc. Product quality and assigned (b)(4). Additional info is being requested. If received, the case will be updated accordingly.
Patient Sequence No: 1, Text Type: D, B5
[8307913]
.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 2917293-2009-00006 |
| MDR Report Key | 1553696 |
| Report Source | 04 |
| Date Received | 2009-11-09 |
| Date of Report | 2009-10-28 |
| Date Mfgr Received | 2009-10-28 |
| Date Added to Maude | 2011-03-28 |
| 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 | 3 |
| Initial Report to FDA | 3 |
| 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 10 MG |
| Generic Name | NONE |
| Product Code | KZE |
| Date Received | 2009-11-09 |
| Lot Number | B105 |
| 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 | 2009-11-09 |