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

Model Number MS9698

Device Problems Mechanical Problem (1384); Failure to Deliver (2338); Insufficient Information (3190)

Patient Problems Hyperglycemia (1905); Coma (2417)

Event Date 02/14/2023

Event Type  Injury  

Event Description

Lilly case id: (b)(4).This report is associated with product complaint: pending.This solicited case, reported by a consumer via a patient support program (psp), concerned a 74-year-old male patient of unknown origin.Medical history included cardiac diseases.Concomitant medications were not provided.The patient received insulin lispro protamine suspension 75%/insulin lispro 25% (rdna origin) injections (humalog mix25, 100 u/ml), from a cartridge via a reusable pen, humapen savvio (graphite color), 20 units in morning and 20 units at night, twice daily, subcutaneously, for treatment of diabetes, beginning in 2013.On (b)(6) 2023, after starting insulin lispro protamine suspension 75%/insulin lispro 25%, he experienced that humapen savvio started to rotate on loss which led to no insulin being released but the dose knob was working well.Also, he found that cartridge was full with medication and no consumption had occurred which meant that the pen did not withdraw the medication.Due to the issue with pen, he missed two insulin doses for one day which led him to diabetic coma (pc number: unknown/ lot number: unknown).He then started to withdraw the insulin from cartridge by insulin syringe to take his doses till he would receive a new humapen.He was not hospitalized for the diabetic coma and received the treatment (unspecified) for it at home.Event of diabetic coma was considered to be serious by the company due to medically significant reason.Information regarding corrective treatment for remaining event was not provided.Events had resolved on (b)(6) 2023.Treatment with insulin lispro protamine suspension 75%/insulin lispro 25% was continued.The operator of suspect humapen savvio was patient and his training status was not provided.The model and suspect humapen savvio duration of use was not provided.The action taken with suspect humapen savvio was not provided but it was available for return.The reporting consumer did not relate the events with insulin lispro protamine suspension 75%/insulin lispro 25% treatment but related them to with suspect humapen savvio.Edit 24feb2023: updated medwatch fields for expedited device reporting.No new information added.

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.

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 24mar2023 in the b.5.Field.No further follow-up is planned.Evaluation summary: the son of a male patient reported that the patient's humapen savvio device "is rotating loosely without loading a dose." this "led to no insulin being released but the dose knob was working well.Also, he found that cartridge was full with medication and no consumption had occurred which meant that the pen did not withdraw the medication." he then started to withdraw the insulin from the cartridge by insulin syringe to take his doses until he would receive a new humapen.The patient experienced diabetic coma.The device was not returned to the manufacturer for investigation (batch 1405v04, manufactured may 2014).Therefore, it could not be evaluated to confirm the complaint or presence of a malfunction.Malfunction unknown.The total number of complaints received for the batch is within the established batch threshold and the batch is not atypical.In addition, a complaint history review did not identify any atypical findings with regards to dose accuracy issues.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.Based on the reported batch number, the device was manufactured in 2014.It is likely the patient used the device beyond its approved use life.The core instructions for use state the humapen savvio has been designed to be used for up to 6 years after first use.The core instruction for use state to always carry a spare insulin pen in case your pen is lost or damaged.The patient reported changing the pen's needle every three or four days.The core instructions for use state use a new needle for each injection.There is evidence of improper use.The user likely used the device beyond its approved use life.It is unknown if this misuse is relevant to the complaint or the event of diabetic coma.The user reused needles, which may be relevant to the complaint and event.

Event Description

Lilly case id: (b)(6).This report is associated with product complaint: (b)(4).This solicited case, reported by a consumer via a patient support program (psp), concerned a 74-year-old male patient of unknown origin.Medical history included cardiac diseases.Concomitant medications were not provided.The patient received insulin lispro protamine suspension 75%/insulin lispro 25% (rdna origin) injections (humalog mix25, 100 u/ml), from a cartridge via a reusable pen, humapen savvio (graphite color), 20 units in morning and 20 units at night, twice daily, subcutaneously, for treatment of diabetes, beginning in 2013.On (b)(6) 2023, after starting insulin lispro protamine suspension 75%/insulin lispro 25%, he experienced that humapen savvio started to rotate on loss which led to no insulin being released but the dose knob was working well.Also, he found that cartridge was full with medication and no consumption had occurred which meant that the pen did not withdraw the medication.Due to the issue with pen, he missed two insulin doses for one day which led him to diabetic coma (pc number: (b)(4)/ lot number: 1405v04).He then started to withdraw the insulin from cartridge by insulin syringe to take his doses till he would receive a new humapen.He was not hospitalized for the diabetic coma and received the treatment (unspecified) for it at home.Event of diabetic coma was considered as serious by the company due to medically significant reason.On an unknown date, he had weakness vision related to the old age.So, he could not read the graduation on barrel of insulin syringe which might lead to inaccurate dose administration (no dose inaccuracy occurred, and it was just his fear), but the humapen was easier regarding adjusting the dose and he could read the units precisely.Also, he was suffering from forgetfulness related to the age.Information regarding corrective treatment for remaining event was not provided.Outcome of the events visual impairment and forgetfulness was not recovered while rema.Ining events recovered on (b)(6) 2023.Treatment with insulin lispro protamine suspension 75%/insulin lispro 25% was continued.Patient was the operator of suspect humapen savvio device, and his training status was not provided.The general humapen device model duration of use and suspect humapen savvio duration of use was not provided.Action taken with suspect humapen savvio was not provided and device was not returned to the manufacturer for investigation.The reporting consumer did not relate the events with insulin lispro protamine suspension 75%/insulin lispro 25% treatment.The reporting consumer did not relate the events of visual impairment and forgetfulness with suspect humapen savvio device and related remaining events with suspect humapen savvio device.Edit 24feb2023: updated medwatch fields for expedited device reporting.No new information added.Update 28-feb-2023: information was received from rcp on 23-feb-2023 which contained only product complaint (pc) number.Pc was processed accordingly.No clinically significant information was received.Hence no changes were done to the case.Update 03-mar-2023: information was received on 01-mar-2023 from the initial reporter via psp.No new medically significant information was received.Hence, no changes were made to the case.Update 08mar2023: : additional information received on 05mar2023 from global product complaint database.Updated lot number from unknown to 1405v04 for product complaint number (b)(4) relating to the suspect humapen savvio (graphite) device.Corresponding fields and narrative updated accordingly.Update 23-mar-2023: additional information was received from initial reporter on 18-mar-2023 via psp.Added two non-serious events of visual impairment and forgetfulness.Updated narrative and causality statement with new information.Update 24mar2023: additional information received on 23mar2023 from the global product complaint database.Entered device specific safety summary (dsss) for humapen savvio (graphite)device associated with (b)(5), lot 1405v04.Updated the medwatch fields/ european and canadian (eu/ca) device information, improper use or storage was updated from no to yes and device return status to not returned to manufacturer.Added date of manufacturer for the device.Corresponding fields and narrative updated accordingly.Edit 27mar2023: upon review of follow up received on 23mar2023 medically significant edit was raised to update device specific safety summary (dsss) in corresponding lss analysis summary (for reporting form) field for humapen savvio (graphite) device associated with (b)(4), lot 1405v04.

• Brand Name: HUMAPEN SAVVIO 3ML (GRAPHITE)
• Type of Device: FOR TREATMENT PURPOSES
• Manufacturer (Section D): ELI LILLY AND COMPANY; lilly corporate center; indianapolis IN 46285
• Manufacturer (Section G): ELI LILLY AND COMPANY; lilly corporate center; indianapolis IN 46285
• Manufacturer Contact: chris davis ; lilly corporate center; indianapolis, IN 46285 ; 3174334585
• MDR Report Key: 16436668
• MDR Text Key: 310162207
• Report Number: 1819470-2023-00016
• Device Sequence Number: 1
• Product Code: FMF
• Combination Product (y/n): N
• Reporter Country Code: EG
• PMA/PMN Number: K160668
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Study,Consumer,Company Representative
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date: 04/04/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/24/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Model Number: MS9698
• Device Lot Number: 1405V04
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 03/23/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 05/31/2014
• 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
• Patient Outcome(s): Other
• Patient Age: 74 YR
• Patient Sex: Male