MAUDE Adverse Event Report: ELI LILLY AND COMPANY HUMAPEN, UNKNOWN DEVICE; FOR TREATMENT PURPOSES

Model Number UNKNOWN

Device Problems Break (1069); Display or Visual Feedback Problem (1184); Protective Measures Problem (3015)

Patient Problems Hyperglycemia (1905); Hypoglycemia (1912)

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)(6).This report is associated with product compliant: pending.This solicited case, reported by a consumer via patient support program (psp), concerned an (b)(6(-year old female of unknown origin.Medical history and concomitant medications was not provided.The patient received human insulin (rdna origin) (humulin r) unknown formulation, for the treatment of type-ii diabetes mellitus, started on unknown date.Dosage regimen was not provided.On unknown date, while on human insulin treatment, she suffered high blood glucose level and hypoglycemia.Her pen was broken and her blood glucose (bg) level increased to 500-600 level.The blood glucose level sometimes decreased to 50-40 level.Her blood glucose meter gave error and could not measure the blood glucose level.Now, her blood glucose level was 200-250.The emergency service employee went to her 1-2 months ago (around (b)(6) 2018).The pen was requested from her and new pen was delivered.The event of bg increased and hypoglycemia was considered as serious due to medically significant reason.Information regarding corrective treatment and outcome for the events and was not provided.Status of human insulin treatment was not provided.The operator of humapen and his/her training status was not provided.The device model duration of use was not provided and suspect device duration of use was approximately 20-25 years.The action taken with the suspect device and its return was not provided.The reporting consumer did not provide the relatedness opinion between the events and human insulin drug or humapen.

Event Description

Lilly case id: (b)(4).This report is associated with product compliant: (b)(4).This solicited case, reported by a consumer via patient support program (psp), concerned an 85-year old female of unknown origin.Medical history and concomitant medications was not provided.The patient received human insulin (rdna origin) (humulin r) unknown formulation, for the treatment of type-ii diabetes mellitus, started on unknown date.Dosage regimen was not provided.On unknown date, while on human insulin treatment, she suffered high blood glucose level and hypoglycemia.Her pen was broken and her blood glucose (bg) level increased to 500-600 level ((b)(4), lot no.Unknown).The blood glucose level sometimes decreased to 50-40 level.Her blood glucose meter gave error and could not measure the blood glucose level.Now, her blood glucose level was 200-250.The emergency service employee went to her one to two months ago (around (b)(6) 2018).The pen was requested from her and new pen was delivered.The event of bg increased and hypoglycemia was considered as serious due to medically significant reason.Information regarding corrective treatment and outcome for the events and was not provided.Status of human insulin treatment was not provided.The operator of humapen and his/her training status was not provided.The device model duration of use was not provided and suspect device duration of use was approximately 20-25 years.The action taken with the suspect device and it was not returned to the manufacturer.The reporting consumer did not provide the relatedness opinion between the events and human insulin drug or humapen.Edit 08nov2018: updated medwatch and european and canadian (eu/ca) fields for expedited device reporting.No new information added.Edit 10-jan-2019: the case was re-opened to process the pc and to set the action item for pc.No other changes were made in the case.Update 03apr2019: additional information received on 02apr2019 and 05apr2019 from the global product complaint database were processed together.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 for the suspect device associated with (b)(4).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 statement dated 05apr2019 in the b.5.Field.No further follow up is planned.Evaluation summary: a female patient reported that her humapen (unspecified device) was broken.She experienced increased blood glucose and hypoglycemia.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 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 reported using the device for 20 to 25 years.The humapen core instructions for use indicate the timeframe for which a device model has been designed to be used.Twenty to 25 years exceeds the timeframe for any humapen model.There is evidence of improper use.The patient used the device beyond its approved use life.It is unknown if this misuse is relevant to the events of increased blood glucose and hypoglycemia.

• Brand Name: HUMAPEN, UNKNOWN DEVICE
• Type of Device: FOR TREATMENT PURPOSES
• Manufacturer (Section D): ELI LILLY AND COMPANY; lilly corporate center; indianapolis IN 46285
• MDR Report Key: 8096304
• MDR Text Key: 128252504
• Report Number: 1819470-2018-00200
• Device Sequence Number: 1
• Product Code: FMF
• Combination Product (y/n): N
• 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: 04/30/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/21/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Other
• Device Model Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 04/02/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 85 YR