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

Model Number MS9557

Device Problem Device Inoperable (1663)

Patient Problems Hyperglycemia (1905); Visual Impairment (2138)

Event Type  Injury  

Manufacturer Narrative

If device is returned, evaluation will be performed to determine if a malfunction has occurred.This is an initial report.A report will be submitted when the final evaluation has been completed.This report is associated with 1819470-2017-00066, since there is more than one device implicated.

Event Description

(b)(4).This spontaneous case, reported by a consumer who contacted the company to report adverse events, concerned a female patient of unspecified age and origin.Medical history included fundus hemorrhage and feet numbness.Concomitant medications included acarbose for an unknown indication.The patient took insulin lispro protamine suspension 50% / insulin lispro 50% (rdna origin) (humalog mix 50) 14 units in the morning and 10 units in the evening from a cartridge via a reusable pen (humapen ergo ii) subcutaneously for the treatment of diabetes beginning approximately in 2014.On an unknown date, she was experiencing issues with her ergo ii devices reported as the insulin did not inject into internal and due to this, her blood sugar went high (values or units were not provided).On (b)(6) 2016, she was hospitalized due to the blood sugar increased and she was discharged on (b)(6) 2016.Further hospitalization information including corrective treatment and laboratory tests were not provided.Also, it was reported that since an unknown date, her eyes were not good (no additional information provided) ((b)(4) / lot number unknown; (b)(4) / lot number: 1509d03).The outcome of the events and corrective treatments were not provided.Insulin lispro protamine suspension 50% / insulin lispro 50% treatment was continued.The operator of the device and her training status were not provided the device model duration of use was three years.The first reported suspect device duration of use was three years and the second reported suspect device duration of use was four moths.The status of the devices is unknown.The reporting nurse was unsure if the event was related to insulin lispro protamine suspension 50% / insulin lispro 50% treatment or not.Edit 29mar2017.Case was opened to enter medwatch device fields for device mailing.No new information.Update 03apr2017: additional information was received on 27mar2017 from the rcp.Pcs were processed.No additional changes.

Manufacturer Narrative

This report is associated with 1819470-2017-00066, since there is more than one device implicated.Evaluation summary: a female patient reported that her humapen ergo ii device had a malfunction but did work well after a new needle was attached.She experienced increased blood glucose.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 device functionality and dose accuracy with high probability.The patient stated that her eyes are "not very good." the instructions for use state the "humapen ergo ii is not recommended for the blind or visually impaired without the assistance of a sighted individual trained to use it." there is evidence of improper use.The patient used the device and was visually impaired.It is unknown if this is relevant to the event of increased blood glucose.

Event Description

Lilly case id: (b)(6).This spontaneous case, reported by a consumer who contacted the company to report adverse events, concerned a female patient of unspecified age and origin.Medical history included fundus hemorrhage and feet numbness.Concomitant medications included acarbose for an unknown indication.The patient took insulin lispro protamine suspension 50% / insulin lispro 50% (rdna origin) (humalog mix 50) 14 units in the morning and 10 units in the evening from a cartridge via a reusable pen (humapen ergo ii) subcutaneously for the treatment of diabetes beginning approximately in 2014.On an unknown date, she was experiencing issues with her ergo ii devices reported as the insulin did not inject into internal and due to this, her blood sugar went high (values or units were not provided).On (b)(6) 2016, she was hospitalized due to the blood sugar increased and she was discharged on (b)(6) 2016.Further hospitalization information including corrective treatment and laboratory tests were not provided.Also, it was reported that since an unknown date, her eyes were not good (no additional information provided) (pc: 3946160/ lot number unknown; pc: 3946163 / lot number: 1509d03).The outcome of the events and corrective treatments were not provided.Insulin lispro protamine suspension 50% / insulin lispro 50% treatment was continued.The consumer was the operator of the device.Her training status were not provided there was evidence of improper use as the operator was visually impaired.The device model duration of use was three years.The first reported suspect device duration of use was three years and the second reported suspect device duration of use was four moths.The status of the devices is unknown.The reporting nurse was unsure if the event was related to insulin lispro protamine suspension 50% / insulin lispro 50% treatment or not.Edit 29mar2017.Case was opened to enter medwatch device fields for device mailing.No new information.Update 03apr2017: additional information was received on 27mar2017 from the rcp.Pcs were processed.No additional changes.Update 25apr2017.Additional information received 24apr2017 from the product complaint safety database.On the device tabs changed improper use to yes, entered the device specific safety summaries (dsss), updated the european and (b)(4) device information, updated the medwatch fields with the device information, and the narrative was updated accordingly.

• 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: 6472069
• MDR Text Key: 72123766
• Report Number: 1819470-2017-00065
• 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: consumer,foreign
• Type of Report: Initial,Followup
• Report Date: 04/07/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/07/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Model Number: MS9557
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 04/24/2017
• 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
• Treatment: GLUCOBAY; HUMALOG LISPRO
• Patient Outcome(s): Hospitalization