MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative,consum report with the FDA on 2020-03-19 for HUMAPEN ERGO II MS9557 manufactured by Eli Lilly And Company.
[188255605]
If device is returned, evaluation will be performed to determine if a malfunction has occurred. This is an initial report. A follow-up report will be submitted when the final evaluation is completed.
Patient Sequence No: 1, Text Type: N, H10
[188255606]
Lilly case id: (b)(4). This report is associated with product complaint: (b)(4). This solicited case reported by consumer via patient support program (psp) and product complaints (pcs), concerned a (b)(6) year-old (at the time of initial report) female patient of unknown origin. Medical history was not reported. Concomitant medications included pantoprazole and pentoxifylline for gastric disorders, vortioxetine hydrobromide and dexamethasone for memory impairment, ezetimibe and simvastatin for neuro disorders, memory impairment and blood circulation, bisoprolol fumarate and ramipril for hypertension, clopidogrel bisulfate for cardiac disorder, metformin hydrochloride and vildagliptin for liver and pancreas disorders. The patient received human insulin isophane suspension 70%/human insulin 30% (rdna origin) injections (humulin mix 70/30) from cartridge via reusable humapen devices at a dose of 30 units in the morning and 10 units at night twice daily subcutaneously for the treatment of diabetes mellitus beginning on an unknown date in 2015. Approximately in 2017, she had replaced her humapen unknown device with humapen ergo ii. Intermittently on an unspecified onset and time, while on human insulin isophane suspension 70%/human insulin 30%, her blood glucose level was sometimes unstable, in which it sometimes decreased to the range of 70-100 mg/dl if she refused to eat or refused to complete her proper meal. In (b)(6) 2019, she experienced severe hypoglycemia and her blood glucose reached to 20 mg/dl. She was hospitalized for hypoglycemia to maintain the blood glucose level. After five days of hospitalization, she recovered. On (b)(6) 2020, her humapen ergo ii plunger had stuck and does not move up or down and the insulin was heavily dispensed, however the complete doses are administered but with difficulty. On (b)(6) 2020, her humapen ergo ii had been completely impaired but no doses were missed. Information regarding corrective treatment for the events was not reported. She was not recovered from the event unstable blood glucose (decreased). Human insulin isophane suspension 70%/human insulin 30% was continued. The patient was operator of the humapen unknown device and humapen ergo ii and her training status was unknown. The general humapen unknown device model duration of use and suspect duration of use was not provided. The general humapen ergo ii model duration of use and suspect humapen ergo ii model duration for use were noted to be approximately 34 months (beginning around (b)(6) 2017). There was no reported complaint for humapen unknown device and its return was not expected the patient continued to use humapen ergo ii and its return was expected. The reporting consumer did not know if the event unstable blood glucose was related or not to insulin human insulin isophane suspension 70%/human insulin 30% and did not considered the event of severe hypoglycemia to human insulin isophane suspension 70%/human insulin 30%. The reporting consumer did not relate events to humapen devices. Edit 16mar2020: updated medwatch fields for expedited device reporting. No new information added.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1819470-2020-00021 |
| MDR Report Key | 9856453 |
| Report Source | COMPANY REPRESENTATIVE,CONSUM |
| Date Received | 2020-03-19 |
| Date of Report | 2020-03-19 |
| Date of Event | 2019-12-31 |
| Date Mfgr Received | 2020-02-22 |
| Date Added to Maude | 2020-03-19 |
| 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 | 3 |
| Event Location | 3 |
| Manufacturer Contact | MR. CHRIS DAVIS |
| Manufacturer Street | LILLY CORPORATE CENTER |
| Manufacturer City | INDIANAPOLIS, IN |
| Manufacturer G1 | PHILLIPS-MEDISIZE CORPORATION |
| Manufacturer Street | 415 RED CEDAR STREET MEDICAL DEVICE MANUFACTURING |
| Manufacturer City | MENOMONIE, |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | HUMAPEN ERGO II |
| Generic Name | FOR TREATMENT PURPOSES |
| Product Code | FMF |
| Date Received | 2020-03-19 |
| Model Number | MS9557 |
| Lot Number | 0909D01 |
| Operator | LAY USER/PATIENT |
| Device Availability | Y |
| Device Eval'ed by Mfgr | N |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | ELI LILLY AND COMPANY |
| Manufacturer Address | LILLY CORPORATE CENTER INDIANAPOLIS, |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Hospitalization | 2020-03-19 |