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

Model Number MS9557

Device Problems Inaccurate Delivery (2339); Difficult to Advance (2920)

Patient Problems High Blood Pressure/ Hypertension (1908); No Code Available (3191)

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 follow-up report will be submitted when the final evaluation is completed.

Event Description

Lilly case id: (b)(4).This report is associated with product compliant: (b)(4).This spontaneous case, reported by a consumer who contacted the company to report an adverse event and a product complaint (pc), concerned a (b)(6) female patient of unknown origin.Medical history included a hospitalization for unspecified reasons.Concomitant medications included acarbose and metformin for unknown indications.The patient received human insulin (rdna origin) injections (humulin 100 u) through cartridges, via reusable humapen ergo ii device, for the treatment of diabetes mellitus.Dosage regimen and start date were not reported.On an unspecified date her blood glucose control was poor (no values reported) and because of it she was hospitalized.While in the hospital her physician switched her to insulin lispro protamine suspension 50%/ insulin lispro 50% (rdna origin) injections (humalog mix50 100 u) through cartridges, via reusable pen (humapen ergo ii), 24 units each morning and 16 units each evening, subcutaneously for the treatment of diabetes mellitus.Start date was not reported.While in the hospital she was diagnosed with high blood pressure and high blood lipids (no values reported for neither).Further details regarding the hospitalization including release date were not reported.On the evening of (b)(6) 2019 she tried injecting 16 units but because the injection button of the humapen ergo ii device could not be pushed down all the way she was only able to get 3 units.On the morning of (b)(6) 2019 she was not able to inject her dose because the injection button of the humapen ergo ii could not be pushed down at all (pc (b)(4), lot 0906d04).Information regarding corrective treatment and outcome of the events was not reported.Insulin lispro protamine suspension 50%/ insulin lispro 50% treatment was continued.The patient was the operator of the humapen ergo ii device and her training status was unknown.The general and suspect humapen ergo ii durations of use were not reported.The suspect humapen ergo ii device associated with pc (b)(4) was returned to the manufacturer on 26feb2019.The reporting consumer did not know if the events were related to human insulin or insulin lispro protamine suspension 50%/ insulin lispro 50%.The reporting consumer related the incorrect dose and the dose omission to the humapen ergo ii device and did not provide an assessment for the remaining events.Update 28feb2019: additional information received on (b)(4) 2019 from global product complaint database.Recoded the suspect humapen luxura, champagne device to a humapen ergo ii device.Updated the lot number from 1201b02 to 0906d04 and the device return status to returned to manufacturer.Added date returned to manufacturer for the humapen ergo ii device associated with product complaint (b)(4).Corresponding fields and narrative updated accordingly.Edit 06mar2019: updated medwatch fields for expedited device reporting.No new information added.

Manufacturer Narrative

B.5.Narrative field; new updated and corrected information is referenced within the update statements in b.5.Please refer to statement dated 04apr2019 in the b.5.Field.No further follow up is planned.Evaluation summary: a female patient reported that on 18feb2019 injection button of her humapen ergo ii device could not be pushed down all the way, she was only able to get 3 u.On 19-feb-2019, she was not able to inject her dose because the injection button of the ergo ii could not be pushed down at all.The patient experienced inadequate diabetes mellitus control.The investigation of the returned device (batch 0906d04, mfrd june 2009) found device met functional requirements for initial priming; however, further investigation of device found device body severely cracked near lens/ bezel, consistent with excessive force applied while in the field.The soft touch was debonded and interfered with the dial/injection button rotation, thus not allowing the dial return to zero without increased injection force.Due to this damage, no further testing could be conducted.Malfunction confirmed.This damage is consistent with exposure to an unknown chemical while in the field.The cartridge holder device thread end is cracked, white crazing of the cartridge holder further supports exposure to an unknown chemical, which can weaken the material.User manual describes proper care and storage of the device and states "do not use alcohol, hydrogen peroxide, bleach, cover in liquid or apply lubrication such as oil, as this could damage the pen.While unknown how long patient used device, based on the amount of time elapsed since the device was manufactured (june 2009), it is likely the patient used it beyond its approved use life.User manual states ergo ii has been designed to be used for up to 3 years after first use.There is evidence of improper use.The device body, soft touch damage, cartridge holder damage are consistent with damage while in the field.This may be relevant to the event of inadequate diabetes mellitus control.Additionally, patient likely used device beyond its approved use life.Is unknown if this is relevant to the event inadequate diabetes mellitus control.

Event Description

Lilly case id: (b)(4).This spontaneous case, reported by a consumer who contacted the company to report an adverse event and a product complaint (pc), concerned a 79 year-old female patient of unknown origin.Medical history included a hospitalization for unspecified reasons.Concomitant medications included acarbose and metformin for unknown indications.The patient received human insulin (rdna origin) injections (humulin 100 u) through cartridges, via reusable humapen ergo ii device, for the treatment of diabetes mellitus.Dosage regimen and start date were not reported.On an unspecified date her blood glucose control was poor (no values reported) and because of it she was hospitalized.While in the hospital her physician switched her to insulin lispro protamine suspension 50%/ insulin lispro 50% (rdna origin) injections (humalog mix50 100 u) through cartridges, via reusable pen (humapen ergo ii), 24 units each morning and 16 units each evening, subcutaneously for the treatment of diabetes mellitus.Start date was not reported.While in the hospital she was diagnosed with high blood pressure and high blood lipids (no values reported for neither).Further details regarding the hospitalization including release date were not reported.On the evening of (b)(6) 2019 she tried injecting 16 units but because the injection button of the humapen ergo ii device could not be pushed down all the way she was only able to get 3 units.On the morning of (b)(6) 2019 she was not able to inject her dose because the injection button of the humapen ergo ii could not be pushed down at all ((b)(4), lot 0906d04).Information regarding corrective treatment and outcome of the events was not reported.Insulin lispro protamine suspension 50%/ insulin lispro 50% treatment was continued.The patient was the operator of the humapen ergo ii device and her training status was unknown.The general and suspect humapen ergo ii durations of use were not reported.The suspect humapen ergo ii device associated with (b)(4) was returned to the manufacturer on 26feb2019.The reporting consumer did not know if the events were related to human insulin or insulin lispro protamine suspension 50%/ insulin lispro 50%.The reporting consumer related the incorrect dose and the dose omission to the humapen ergo ii device and did not provide an assessment for the remaining events.Update 28feb2019: additional information received on 26feb2019 from global product complaint database.Recoded the suspect humapen luxura, champagne device to a humapen ergo ii device.Updated the lot number from 1201b02 to 0906d04 and the device return status to returned to manufacturer.Added date returned to manufacturer for the humapen ergo ii device associated with product complaint (b)(4).Corresponding fields and narrative updated accordingly.Edit 06mar2019: updated medwatch fields for expedited device reporting.No new information added.Update 04apr2019: additional information received on 02apr2019 from the global product complaint database.Entered the device specific safety summary (dsss).Updated the medwatch and european and canadian (eu/ca) device fields, improper use and storage from no to yes, and malfunction from unknown to yes, not cirm.Added the date of manufacture for the suspect device associated with (b)(4).Corresponding fields and narrative 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
• MDR Report Key: 8426146
• MDR Text Key: 138995253
• Report Number: 1819470-2019-00027
• 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: 04/25/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Model Number: MS9557
• Device Lot Number: 0906D04
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/26/2019
• Initial Date Manufacturer Received: 02/19/2019
• Initial Date FDA Received: 03/15/2019
• Supplement Dates Manufacturer Received: 04/02/2019
• Supplement Dates FDA Received: 04/25/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization
• Patient Age: 79 YR
• Patient Weight: 70