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

Model Number MS9694

Device Problems Fitting Problem (2183); Detachment of Device or Device Component (2907); Physical Resistance/Sticking (4012)

Patient Problems Fall (1848); Hypoglycemia (1912); Seizures (2063)

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.This report is associated with 1819470-2018-00207 since there is more than one device implicated.

Event Description

Lilly case id: (b)(4).This report is associated with product compliant: (b)(4).This spontaneous case, reported by a consumer who intended to report a product complaint, concerns a male patient of unknown age and ethnicity.Medical history and concomitant medication were not provided.The patient received insulin glargine (rdna origin) (basaglar) cartridge via humapen ergo ii and humapen savvio red unknown dose, frequency, route of administration, indication for use and start date.On an unspecified date and time after starting insulin glargine via humapen ergo ii (lot number 1703d02) and humapen savvio red (lot number 1611v09) treatment, the patient experienced a hypoglycemia episode that lead him to experience a seizure that caused a fall and the patient hit his head.It was also mentioned that the patient did not see well and that this seizure was not the only one he experienced.The company considered the hypoglycemia, the seizures, the fall and hitting the head as serious due to medically significant reasons.Corrective treatments, outcome of events and information regarding exams were not provided.In addition, reporting consumer informed that the plunger (cursor) of one of the devices (not specified) did not fit the insulin cartridge and thought the problem was the insulin glargine cartridge (lot number: c833552c / product complaint number: (b)(4)); it was mentioned that many patients were with this same problem of not being able to make the insulin to rise.A procedure was performed with humapen savvio red once and the insulin did not came out; a second procedure was performed and the insulin did not came out again.The reporting consumer tried to select the units for the procedure (60iu) again and it was stuck on 2iu.It was unknown if any action was taken with insulin glargine treatment or its status.The devices operator and if this person was trained were unknown.The patient had used this device model and the reported suspect devices for unknown period.It was unknown if any action was taken with suspect devices.Return status was unknown.Reporting consumer did not provide any relatedness opinions.Edit 03dec2018: updated medwatch and european and canadian (eu/ca) fields for expedited device reporting.No new information added.Edit 04dec2018: updated medwatch fields for expedited device reporting.No new information added.Edit 05dec2018: upon internal review on 05dec2018, humapen savvio was recoded to humapen savvio red based on provided lot number.

Manufacturer Narrative

Event narrative field; new updated and corrected information is referenced within the update statements in event.Please refer to statement dated 13dec2018 in the event field.No further follow up is planned.This report is associated with 1819470-2018-00207 since there is more than one device implicated.Evaluation summary: a male patient reported having both a humapen ergo ii device and a humapen savvio device.He reported that when using one of the devices (unspecified which one) "the plunger (device's injection screw) does not get into the insulin." he thought the problem might be with the insulin cartridge.Troubleshooting was performed for the savvio device with a trained professional, but insulin did not come out and the device was stuck on 2iu.The patient experienced hypoglycemia.The savvio device was not returned to the manufacturer for investigation (batch: 1611v09, manufactured november 2016).Therefore, it could not be evaluated to confirm the complaint or presence of a malfunction.Malfunction unknown.A complaint history review of the batch did not identify any atypical findings with respect to pen jams.All humapen savvio devices are assessed for injection screw travel at the end of the manufacturing process, thus ensuring device functionality with high probability.In addition, the patient reported that he "does not see right." the core user manual states the humapen savvio device is not recommended for the blind or the visually impaired without the assistance of a sighted individual trained to use it.There is evidence of improper use.The patient used the device while visually impaired.It is unknown if this is relevant to the event of hypoglycemia.

Event Description

Lilly case id: (b)(4).This spontaneous case, reported by a consumer who intended to report a product complaint, concerns a male patient of unknown age and ethnicity.Medical history and concomitant medication were not provided.The patient received insulin glargine (rdna origin) (basaglar) cartridge via humapen ergo ii and humapen savvio red unknown dose, frequency, route of administration, indication for use and start date.On an unspecified date and time after starting insulin glargine via humapen ergo ii (lot number: 1703d02) and humapen savvio red (lot number: 1611v09) treatment, the patient experienced a hypoglycemia episode that lead him to experience a seizure that caused a fall and the patient hit his head.It was noted that the devices did not get into the insulin (pc 4554472, lot number: 1703d02)(pc 4554473, lot number: 1611v09).It was also mentioned that the patient did not see well and that this seizure was not the only one he experienced.The company considered the hypoglycemia, the seizures, the fall and hitting the head as serious due to medically significant reasons.Corrective treatments, outcome of events and information regarding exams were not provided.In addition, reporting consumer informed that the plunger (cursor) of one of the devices (not specified) did not fit the insulin cartridge and thought the problem was the insulin glargine cartridge (lot number: c833552c / product complaint number: (b)(4); it was mentioned that many patients were with this same problem of not being able to make the insulin to rise.A procedure was performed with humapen savvio red once and the insulin did not came out; a second procedure was performed and the insulin did not came out again.The reporting consumer tried to select the units for the procedure (60iu) again and it was stuck on 2iu.It was unknown if any action was taken with insulin glargine treatment or its status.The devices operator and if this person was trained were unknown.The patient had used this device model and the reported suspect devices for unknown period.It was unknown if any action was taken with suspect devices.The suspect devices were not returned to the manufacturer.Reporting consumer did not provide any relatedness opinions.Edit 03dec2018: updated medwatch and european and canadian (eu/ca) fields for expedited device reporting.No new information added.Edit 04dec2018: updated medwatch fields for expedited device reporting.No new information added.Edit 05dec2018: upon internal review on 05dec2018, humapen savvio was recoded to humapen savvio red based on provided lot number.Update 13dec2018: additional information received on 13dec2018 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 added date of manufacturer for the suspect device associated with pc 4554472 and pc 4554473.Corresponding fields and narrative updated accordingly.Update 17dec2018: additional information received on 17dec2018 from the global product complaint database.Entered updated device specific safety summary (dsss).Updated the medwatch/european and canadian (eu/ca) device information relating to product complaint: (b)(4) with associated lot of 1703d02 of humapen ergo ii device.Corresponding fields and narrative updated accordingly.

• Brand Name: HUMAPEN SAVVIO 3ML (RED)
• Type of Device: FOR TREATMENT PURPOSES
• Manufacturer (Section D): ELI LILLY AND COMPANY; lilly corporate center; indianapolis IN 46285
• MDR Report Key: 8138697
• MDR Text Key: 129525471
• Report Number: 1819470-2018-00206
• 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: 01/08/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/06/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Other
• Device Model Number: MS9694
• Device Lot Number: 1611V09
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 12/13/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other