MAUDE Adverse Event Report: ELI LILLY AND COMPANY HUMAPEN SAVVIO 3ML (UNKNOWN COLOR); FOR TREATMENT PURPOSES

Model Number UNKNOWN

Device Problems Break (1069); Patient Device Interaction Problem (4001)

Patient Problems Fall (1848); Hyperglycemia (1905); Coma (2417); Underdose (2542); Confusion/ Disorientation (2553)

Event Date 08/31/2019

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 adverse events and product complaints (pc), concerned a (b)(6) male patient of unknown origin.Medical history included diabetes mellitus (dm) type i approximately since 1974 and use of insulin glargine (another manufacturer).Concomitant medications were not provided.The patient received insulin lispro (rdna origin) injections (humalog) from cartridge via a reusable devices (humapen luxura burgundy and humapen savvio), subcutaneously for the treatment of dm type i, beginning on an unknown date.He also received insulin lispro (rdna origin) injections (humalog) via a pre-filled pen (kwikpen junior), subcutaneously for the treatment of dm type i, beginning on an unknown date.On an unknown date, while on insulin lispro treatment (cartridge), he had surgery at his bladder due to the cancer.On an unknown date, while on insulin lispro treatment (cartridge), one time he fell into coma at home due to increased blood glucose (no results or reference values were provided) and was hospitalized.Further details about hospitalization such as admission and discharge dates or any relevant laboratory tests were not provided.He received kwikpen junior and humapen savvio (unknown color) at hospital.On unspecified dates while on insulin lispro (cartridge and pre-filled pen), he went into a coma two more times at the hospital due to increased blood glucose/hyperglycemia (no results or reference values were provided).He was very confused with blood glucose values.Since using kwikpen junior and humapen savvio (unknown color), the mechanics of both devices did not work.On an unknown date, he was unsatisfied and found difficult to use his humapen savvio (unknown color) (lot number: unknown, pc number: 4851753).On an unspecified date, he used insulin lispro via the kwikpen junior but did not know the amount of insulin lispro he was getting although he was not injecting half dosages due to a issue with the pre-filled pen (lot number: c997584k, pc number: 4850118).Since using the humapen savvio (unknown color), insulin lispro only was effective after three hours of injections (lot number: unknown, pc number: 4851754) and approximately on (b)(6) 2019, his blood glucose was 600 mg/dl.The events of cancer and blood glucose 600 mg/dl were considered as serious due to their medical significance.Information regarding corrective treatment of remaining events, outcome of the events and status of insulin lispro treatments (cartridge and disposable) was not provided.Follow up was not possible as the contact details of reporter and physician was not provided.The patient was the operator of kwikpen junior, humapen savvio (unknown color) and humapen luxura burgundy and his training status was not provided.The model duration and suspect device duration for use of humapen luxura burgundy was not provided.The model duration of use of kwikpen junior and humapen savvio (unknown color) started in (b)(6) 2019, while the suspect device duration of use of them was not provided.The action taken with kwikpen junior, humapen savvio (unknown color) and humapen luxura burgundy was not provided and the return status of humapen luxura burgundy was not expected since no complaint was reported, while the status of return of kwikpen junior and humapen savvio (unknown color) was not provided.The initial reporting consumer related the event of efficacy delayed and sequel of high blood glucose at 600 mg/ml to insulin lispro (cartridge and pre-filled pen) while did not provide an opinion of relatedness between the rest of events and insulin lispro treatments (cartridge and pre-filed pen).The initial reporting consumer did not provide an opinion of relatedness between the events and humapen savvio (unknown color) or humapen luxura burgundy.The initial reporting consumer related the event of incorrect dose with product complaint associated with kwikpen junior and did not provide an opinion of relatedness between the remaining events and kwikpen junior.Edit (b)(6) 2019: upon review of the initial information received on (b)(6) 2019, corrected the coding of suspect device humapen savvio from humapen savvio (red) to humapen savvio (unknown color).No other changes were made to the case.Edit (b)(6) 2019: updated medwatch and european and canadian (eu/ca) 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 update statement(s) dated 29oct2019 in the b.5.Field.No further follow-up is planned.Evaluation summary: a male patient reported the mechanism of his humapen savvio device does not work and the insulin "is taking effect 3 hours late." he experienced hyperglycemic coma and 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 savvio devices are assessed for injection screw travel at the end of the manufacturing process, thus ensuring device functionality and dose accuracy with high probability.There is no evidence of improper use or storage.

Event Description

Lilly case id: (b)(4).This spontaneous case, reported by a consumer who contacted the company to report adverse events and product complaints (pc), concerned a 74-year-old male patient of unknown origin.Medical history included diabetes mellitus (dm) type i approximately since 1974 and use of insulin glargine (another manufacturer).Concomitant medications were not provided.The patient received insulin lispro (rdna origin) injections (humalog) from cartridge via a reusable devices (humapen luxura burgundy and humapen savvio), subcutaneously for the treatment of dm type i, beginning on an unknown date.He also received insulin lispro (rdna origin) injections (humalog) via a pre-filled pen (kwikpen junior), subcutaneously for the treatment of dm type i, beginning on an unknown date.On an unknown date, while on insulin lispro treatment (cartridge), he had surgery at his bladder due to the cancer.On an unknown date, while on insulin lispro treatment (cartridge), one time he fell into coma at home due to increased blood glucose (no results or reference values were provided) and was hospitalized.Further details about hospitalization such as admission and discharge dates or any relevant laboratory tests were not provided.He received kwikpen junior and humapen savvio (unknown color) at hospital.On unspecified dates while on insulin lispro (cartridge and pre-filled pen), he went into a coma two more times at the hospital due to increased blood glucose/hyperglycemia (no results or reference values were provided).He was very confused with blood glucose values.Since using kwikpen junior and humapen savvio (unknown color), the mechanics of both devices did not work.On an unknown date, he was unsatisfied and found difficult to use his humapen savvio (unknown color) (lot number: unknown, pc number: (b)(4)).On an unspecified date, he used insulin lispro via the kwikpen junior but did not know the amount of insulin lispro he was getting although he was not injecting half dosages due to a issue with the pre-filled pen (lot number: c997584k, pc number: (b)(4)).Since using the humapen savvio (unknown color), insulin lispro only was effective after three hours of injections (lot number: unknown, pc number: (b)(4)) and approximately on (b)(6) 2019, his blood glucose was 600 mg/dl.The events of cancer and blood glucose 600mg/dl were considered as serious due to their medical significance.Information regarding corrective treatment of remaining events, outcome of the events and status of insulin lispro treatments (cartridge and disposable) was not provided.Follow up was not possible as the contact details of reporter and physician was not provided.The patient was the operator of kwikpen junior, humapen savvio (unknown color) and humapen luxura burgundy and his training status was not provided.The model duration and suspect device duration for use of humapen luxura burgundy was not provided.The model duration of use of kwikpen junior and humapen savvio (unknown color) started in (b)(6) 2019, while the suspect device duration of use of them was not provided.The action taken with kwikpen junior, humapen savvio (unknown color) and humapen luxura burgundy was not provided and the return status of humapen luxura burgundy was not expected since no complaint was reported, while the status of return of kwikpen junior and humapen savvio (unknown color) were not returned to the manufacturer.The initial reporting consumer related the event of efficacy delayed and sequel of high blood glucose at 600 mg/ml to insulin lispro (cartridge and pre-filled pen) while did not provide an opinion of relatedness between the rest of events and insulin lispro treatments (cartridge and pre-filed pen).The initial reporting consumer did not provide an opinion of relatedness between the events and humapen savvio (unknown color) or humapen luxura burgundy.The initial reporting consumer related the event of incorrect dose with product complaint associated with kwikpen junior and did not provide an opinion of relatedness between the remaining events and kwikpen junior.Edit 18-sep-2019: upon review of the initial information received on 21-aug-2019, corrected the coding of suspect device humapen savvio from humapen savvio (red) to humapen savvio (unknown color).No other changes were made to the case.Edit 18sep2019: updated medwatch and european and canadian (eu/ca) fields for expedited device reporting.No new information added.Update 29oct2019: additional information received on 29oct2019 from the global product complaint database.Entered device specific safety summary (dsss).Updated the medwatch fields/ european and canadian (eu/ca) device information and device return status to not returned to manufacturer for the device associated with pc (b)(4)with an unknown lot of humapen savvio (unknown color) device.Corresponding fields and narrative updated accordingly.Update 31oct2019: additional information received on 31oct2019 from the global product complaint database.No new information was added.

• Brand Name: HUMAPEN SAVVIO 3ML (UNKNOWN COLOR)
• Type of Device: FOR TREATMENT PURPOSES
• Manufacturer (Section D): ELI LILLY AND COMPANY; lilly corporate center; indianapolis IN 46285
• MDR Report Key: 9083636
• MDR Text Key: 162273269
• Report Number: 1819470-2019-00165
• Device Sequence Number: 1
• Product Code: FMF
• Combination Product (y/n): N
• PMA/PMN Number: K160668
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer,foreign
• Type of Report: Initial,Followup
• Report Date: 11/19/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/18/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Model Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 10/29/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 74 YR