MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 00,01,04 report with the FDA on 2008-03-05 for HUMAPEN ERGO, TEAL/CLEAR MS8929 UNK manufactured by Eli Lilly And Co..
[785663]
This device case, which does not involve an adverse event, reported by a consumer, who contacted the company with a product complaint, concerns a pt of unk age, sex or origin. The pt was taking an unspecified medication for treatment of an unk indication. In 2007, the humapen ergo teal/clear pen body (unk lot number) with a clear cartridge holder attached was reported to have two locating tabs at the base of the cartridge housing which had snapped off. The pt reported that the pen would not advance the plunger, and it just spins if the locating tabs do not engage. The pt had two humapens and one had developed this problem. This humapen ergo, teal/clear pen body with a clear cartridge holder attached is associated with another device. The operator of the device was unk and it was unk if the operator of the device was trained. It was unk how long the pt had used this device model. The device was not going to be returned to the company for further investigation. It was unk if this humapen ergo teal/clear pen body with a clear cartridge holder attached was continued. Refer to results/conclusion section. Update 04-mar-2008; add'l info received in gpcms 28-feb-2008; added lss summary to qc info tab; updated final fields, further investigation field and deleted expected follow up date on eu/ca device button; updated psur comments and added "refer to results/conclusions section" to narrative.
Patient Sequence No: 1, Text Type: D, B5
[7945906]
Reportable malfunction/near incident identified. Investigation in progress. Note: this report contains final eval findings. No add'l inf is expected. H3. Eval summary: the actual complaint device was not returned to the mfr for investigation, nor was a lot number provided. Therefore no investigation could be performed. However, the complaint narrative clearly suggests that both clear cartridge holder engagement tabs were broken. This reportable malfunction may result in an underdose. Corrective action: the core user manual states "do not damage or remove the cartridge holder tabs. Do not use the pen if the cartridge holder tabs are broken. Do not use the pen if any part of your pen appears broken or damaged. Contact your healthcare professional. Evidence of improper use or storage: there is no evidence of improper use or storage.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 1819470-2008-00014 |
| MDR Report Key | 1007959 |
| Report Source | 00,01,04 |
| Date Received | 2008-03-05 |
| Date of Report | 2007-05-30 |
| Date Mfgr Received | 2007-05-30 |
| Date Added to Maude | 2008-06-04 |
| 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 | 3 |
| Health Professional | 0 |
| Initial Report to FDA | 0 |
| Report to FDA | 0 |
| Event Location | 0 |
| Manufacturer Contact | HAROLD YEAGER |
| Manufacturer Street | LILLY TECHNOLOGY CENTER DC2523 |
| Manufacturer City | INDIANAPOLIS IN 46285 |
| Manufacturer Country | US |
| Manufacturer Postal | 46285 |
| Manufacturer Phone | 3172762000 |
| Manufacturer G1 | MEDICAL DEVICE MFG |
| Manufacturer Street | 415 RED CEDAR ST |
| Manufacturer City | MENOMONIE WI 54751 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 54751 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | HUMAPEN ERGO, TEAL/CLEAR |
| Generic Name | PEN INJECTOR FOR TREATMENT PURPOSES |
| Product Code | KZE |
| Date Received | 2008-03-05 |
| Model Number | MS8929 |
| Catalog Number | UNK |
| Lot Number | UNK |
| ID Number | CID00583375 |
| Operator | OTHER |
| Device Availability | N |
| Device Age | DA |
| Device Eval'ed by Mfgr | N |
| Implant Flag | N |
| Date Removed | B |
| Device Sequence No | 1 |
| Device Event Key | 1006869 |
| Manufacturer | ELI LILLY AND CO. |
| Manufacturer Address | INDIANAPOLIS IN US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2008-03-05 |