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

Model Number MS9557

Device Problems Break (1069); Component Falling (1105); Device Operates Differently Than Expected (2913)

Patient Problem Hyperglycemia (1905)

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 1819470-2017-00080 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 an adverse event and product complaint (pc), concerned a male patient of unknown age and origin.Medical history was not provided.Concomitant medication included metformin for unknown indication.The patient received an unspecified form of insulin lispro (rdna origin) (humalog) per a cartridge via a reusable humapen ergo ii pen and a humapen ergo (teal/clear pen) with a dose of 22 units in the morning and 24 units at night, subcutaneously for the treatment of diabetes mellitus.Start date was not proved.Since an unknown date, during the administration of insulin lispro treatment he was hospitalized for three to four time every year due to high blood glucose (normal reference range and units no were provided).The patient had issues with two humapen devices.He noted that with the first blue plastic pen, a humapen ergo ii pen , the injection screw did not move and he could not tell if the injection button was pushed down ((b)(4)/ lot unknown).With the second blue plastic pen, a humapen ergo (teal/clear) pen, it was dropped and broke on (b)(6) 2018 ((b)(4)/ lot 0508a01).Information regarding corrective treatments, hospitalization dates and outcome of the event was not provided.Insulin lispro treatment was continued.The patient was the operator of the suspect devices and his training status was not provided.The general devices duration of use was not provided.The suspect devices duration of use was not provided.The suspect device with (b)(4) was returned to the manufacturer on 07may2018; other suspect device return status was not provided.The reporting consumer did not know if the event was related to the treatment with insulin lispro and did not provide an assessment of relatedness between the event and the humapen ergo ii and the humapen ergo (teal/clear) pen.Update 08may2018: updated medwatch fields for expedited device reporting.No new information added.Update 09may2018: additional information received on 07may2018 from global product complaint database.Recoded the suspect humapen ergo ii to a humapen ergo (teal/clear) pen.Changed the lot number from 151020b to 0508a01 for (b)(4) relating to the humapen ergo (teal/clear) pen.Added date returned to manufacturer.Corresponding fields and narrative updated accordingly.

Event Description

Lilly case id: (b)(4).This spontaneous case reported by a consumer who contacted the company to report an adverse event and product complaint (pc), concerned a male patient of unknown age and origin.Medical history was not provided.Concomitant medication included metformin for unknown indication.The patient received an unspecified form of insulin lispro (rdna origin) (humalog) per a cartridge via a reusable humapen ergo ii pen and a humapen ergo (teal/clear pen) with a dose of (b)(4) units in the morning and (b)(4) units at night, subcutaneously for the treatment of diabetes mellitus.Start date was not provided.Since an unknown date, during the administration of insulin lispro treatment he was hospitalized for three to four time every year due to high blood glucose (normal reference range and units no were provided).The patient had issues with two humapen devices.He noted that with the first blue plastic pen, a humapen ergo ii pen, the injection screw did not move and he could not tell if the injection button was pushed down (b)(4)/ lot unknown).With the second blue plastic pen, a humapen ergo (teal/clear) pen, it was dropped and broke on (b)(6) 2018 (b)(4)/ lot 0508a01).It was noted that the patient likely used the humapen ergo beyond its approved use life as it is stated in the manual to be used up to three years after first use.In addition, to contact the manufacturer for a replacement pen if it appeared broken or damaged.Information regarding corrective treatments, hospitalization dates and outcome of the event was not provided.Insulin lispro treatment was continued.The patient was the operator of the suspect devices and his training status was not provided.The general devices duration of use was not provided.The suspect devices duration of use was not provided.The suspect device with (b)(4), which was manufactured in aug2005, was returned to the manufacturer on 07may2018; other suspect device with (b)(4) was not returned to the manufacturer (refused to return).The reporting consumer did not know if the event was related to the treatment with insulin lispro and did not provide an assessment of relatedness between the event and the humapen ergo ii and the humapen ergo (teal/clear) pen.Update 08may2018: updated medwatch fields for expedited device reporting.No new information added.Update 09may2018: additional information received on 07may2018 from global product complaint database.Recoded the suspect humapen ergo ii to a humapen ergo (teal/clear) pen.Changed the lot number from 151020b to 0508a01 for product complaint (b)(4) relating to the humapen ergo (teal/clear) pen.Added date returned to manufacturer.Corresponding fields and narrative updated accordingly.Update 25jun2018: additional information received on 25jun2018 from the global product complaint database.Entered device specific safety summary (dsss).Updated the medwatch/european and canadian (eu/ca) device information, improper use and storage from no to yes, malfunction from unknown to no.Added date of manufacturer for (b)(4) associated with 0508a01 lot of an humapen ergo device.Corresponding fields and narrative updated accordingly.Edit 24jul2018: updated medwatch fields for expedited device reporting.No new information added.Update 27jul2018: additional information received on 27jul2018 from the global product complaint database.Entered device specific safety summary (dsss).Updated the medwatch/european and canadian (eu/ca) device information and device return status to not returned to manufacturer for (b)(4) associated with an unknown lot of a humapen ergo ii device.Corresponding fields and narrative updated accordingly.

Manufacturer Narrative

B.5.Narrative field: new, updated and corrected information is referenced within the update statements in b.5.Please refer to update statement dated 27jul2018 in the b.5.Field.No further follow-up is planned.This report is associated with 1819470-2017-00080 since there is more than one device implicated.Evaluation summary: a male patient reported the injection screw of his humapen ergo ii device did not move and he could not tell if the injection button was pushed down.He experienced increased blood glucose.The device was not returned 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 with high probability.There is no evidence of improper use.

• 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: 7541541
• MDR Text Key: 109167305
• Report Number: 1819470-2018-00079
• 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: 08/07/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/24/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Model Number: MS9557
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 07/27/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization