MAUDE Adverse Event Report: ELI LILLY AND COMPANY HUMAPEN ERGO II; FOR TREATMENT PURPOSES

Model Number MS9557

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Hyperglycemia (1905); High Blood Pressure/ Hypertension (1908); Pain (1994)

Event Type  Injury  

Manufacturer Narrative

Since the device is not being returned, evaluation for a malfunction is not possible.This is an initial report.A follow-up report will be submitted when the final evaluation is completed.

Event Description

(b)(4).This solicited case reported by a consumer via a patient support program (psp), concerned a (b)(6) female (b)(6) patient.Medical history included macular degeneration, fundus hemorrhage and looked at things deformation and concomitant medications included metoprolol, acarbose, metformin all of them for unknown indication; also unspecified hypertensive drug and unspecified heart disease drug for unknown indications.The patient received human insulin isophane suspension 70%/human insulin 30% (rdna origin) injection (humulin 70/30) from cartridge via a humapen ergo ii, at 26 iu each morning and 24 iu each evening subcutaneous for the treatment of diabetes, beginning approximately in 2006.On an unspecified date after starting human insulin 70/30 she experienced high blood high blood sugar (postprandial blood glucose was more than 36), hypertension and heart disease and approximately in 2008 or 2009, two or three years after starting human insulin 70/30, she was hospitalized due to these events.Also by that time, she had knee degenerative disease.Furthermore, approximately in 2009 or 2010, humapen ergo ii (unknown lot number, 3703470 pc) was broken down and she thrown away it.In 2015, nine years after starting insulin human 70/30 she was allergic to tomato; her whole body had lumps and itchy and skin damage.On an unspecified date after starting human insulin 70/30, she had leg pain and could not went out, also she was having headache.Information regarding corrective treatment and outcome of the events was not reported.Human insulin 70/30 was continued.The operator of the device was not provided and its training status was unknown.The general device duration of use was not provided but it was started on 2006 and the reported device use of duration was three years.The device was thrown away and it was not returned.The reporting consumer did not know if the events were related to human insulin 70/30 and the device.Update 01jul2016: upon review, this case was opened to update the medwatch fields for regulatory reporting.Edit 07-jul-2016: the pc number was already received and was processed accordingly.No other changes were performed.

Manufacturer Narrative

No further follow up is planned.Continued: evaluation summary a female patient reported while using a humapen ergo ii device that the device had "broken down".She experienced increased blood glucose levels.The device was not returned to the manufacturer for investigation (batch unknown).Therefore, it could not be evaluated to confirm the complaint or presence of a malfunction.Malfunction unknown.All humapen ergo ii devices are assessed for injection screw travel at the end of the manufacturing process, thus ensuring dose accuracy and device functionality with a high probability.There is no evidence of improper use or storage.

Event Description

Lilly case id: (b)(6).This solicited case reported by a consumer via a patient support program (psp), concerned a (b)(6) female asian patient.Medical history included macular degeneration, fundus hemorrhage and looked at things deformation and concomitant medications included metoprolol, acarbose, metformin all of them for unknown indication; also unspecified hypertensive drug and unspecified heart disease drug for unknown indications.The patient received human insulin isophane suspension 70%/human insulin 30% (rdna origin) injection (humulin 70/30) from cartridge via a humapen ergo ii, at 26 iu each morning and 24 iu each evening subcutaneous for the treatment of diabetes, beginning approximately in 2006.On an unspecified date after starting human insulin 70/30 she experienced high blood high blood sugar (postprandial blood glucose was more than 36), hypertension and heart disease and approximately in 2008 or 2009, two or three years after starting human insulin 70/30, she was hospitalized due to these events.Also by that time, she had knee degenerative disease.Furthermore, approximately in 2009 or 2010, humapen ergo ii (unknown lot number, 3703470 pc) was broken down and she thrown away it.In 2015, nine years after starting insulin human 70/30 she was allergic to tomato; her whole body had lumps and itchy and skin damage.On an unspecified date after starting human insulin 70/30, she had leg pain and could not went out, also she was having headache.Information regarding corrective treatment and outcome of the events was not reported.Human insulin 70/30 was continued.The operator of the device was not provided and its training status was unknown.The general device duration of use was not provided but it was started on 2006 and the reported device use of duration was three years.The device was thrown away and it was not returned.The reporting consumer did not know if the events were related to human insulin 70/30 and the device.Update 01jul2016: upon review, this case was opened to update the medwatch fields for regulatory reporting.Edit 07-jul-2016: the pc number was already received and was processed accordingly.No other changes were performed.Update 22-jul-2016: information received from the affiliate on 28-jun-2016 and from the rcp on 30-jun-2016 was processed at the same time.Product complaint number already processed and correction regarding psp intermediate were received.No new adverse event information was received.Update 01-aug-2016: additional information received on 29-jul-2016 from the global product complaint database added the device specific safety summary; added the device was not returned; updated the medwatch and european and canadian required device reporting elements; and updated the narrative.

• Brand Name: HUMAPEN ERGO II
• Type of Device: FOR TREATMENT PURPOSES
• Manufacturer (Section D): ELI LILLY AND COMPANY; lilly corporate center; indianapolis IN 46285
• Manufacturer (Section G): PHILLIPS-MEDISIZE CORPORATION; 415 red cedar street; medical device manufacturing; menomonie WI 54751
• Manufacturer Contact: caroline rosewell ; lilly corporate center; indianapolis, IN 46285 ; 3172764376
• MDR Report Key: 5798179
• MDR Text Key: 49793696
• Report Number: 1819470-2016-00171
• Device Sequence Number: 1
• Product Code: FMF
• Combination Product (y/n): N
• PMA/PMN Number: K151686
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,consum
• Type of Report: Initial,Followup
• Report Date: 06/28/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/15/2016
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Other
• Device Model Number: MS9557
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 07/29/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization
• Patient Age: 73 YR
• Patient Weight: 93