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

Model Number MS9698

Device Problems Improper or Incorrect Procedure or Method (2017); Failure to Deliver (2338)

Patient Problems Fainting (1847); Hyperglycemia (1905); Hypoglycemia (1912); Visual Impairment (2138)

Event Type  Injury  

Manufacturer Narrative

Narrative field; new updated and corrected information is referenced within the update statements.Please refer to statement dated (b)(6) 2017 in the field.No further follow up is planned.Evaluation summary a female patient reported her humapen savvio device would not release insulin when the needle was inserted in her belly; the device only released insulin when the needle was removed from her skin.During troubleshooting, the patient indicated the device "became very hard to press;" the patient indicated it was "as if something was jamming" the device.The patient experienced hypoglycemic unconsciousness.The device was not returned to the manufacturer for investigation (batch 1503v03, manufactured march 2015).Therefore, it could not be evaluated to confirm the complaint or presence of a malfunction.Malfunction unknown.A complaint history review for the batch did not identify any atypical findings with respect to dose accuracy, leaking after injection, or pen jams.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.The patient reported "she was diabetic and it has been getting to her sight." the 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 and storage.The patient used the device while visually impaired; this may be relevant to the event of hypoglycemic unconsciousness.In addition, the patient reused needles and stored the humapen savvio device in the refrigerator with a needle attached.It is unknown if these are relevant to the event of hypoglycemic unconsciousness.

Event Description

Lilly case id: (b)(6) this spontaneous case, reported by a consumer, who contacted the company to report an adverse event with a product complaint, concerns female patient of unspecified age and ethnicity.Medical history: diabetes since 1987.Concomitant medications: liraglutide for diabetes.The patient received human insulin (rdna origin) nph (humulin n) cartridge and human insulin (rdna origin) regular (humulin r) cartridge, 30 iu each morning and 30 iu each evening (did not specify the dose of each insulin), both via unknown route of administration, for diabetes, starting on an unspecified date.The reporter stated that the patient used insulin since 1999, but did not specify which insulin.In 2010, unclear if prior or after starting both human insulin nph and human insulin regular, the patient experienced visual impairment.On an unspecified date, unspecified time after starting both human insulin nph and human insulin regular therapy via humapen savvio 3ml graphite, the patient experienced a lot of peaks (as reported), some days it was around 400 and 500 and some days it was around 50 (units and normal limits not provided) and the patient was fainting.It was reported that, on unspecified dates, the patient went to the hospital due to it (unclear if the patient was hospitalized).The event of glycaemia around 50 with fainting was considered serious by the company due to medically significant reasons.Information regarding laboratory exams, corrective treatment and outcomes was not reported.The patient had visual impairment, reused needles, stored the in-use pen in refrigerator and stored the pen with the needle attached.As of 12apr2017, it was reported that the device was not working because the insulin was not being released when the patient injected on belly, it was only released when the patient removed the needle of skin, very hard to press, and indicated it was as if something was jamming the device (product complaint number (b)(4) /lot number 1503v03.Human insulin nph and human insulin r therapies status were not reported.The patient operated the device and it was unknown if she was trained.The patient had used this device model for unspecified time and the reported humapen savvio 3ml graphite for less than 15 days.The device was not returned to the manufacturer.The reporting consumer did not provide a relatedness opinion.Update 14apr2017: upon review this case was opened to update the medwatch fields for regulatory reporting.Update 18apr2017: additional information was received on 17apr2017 from the initial reporting consumer.Device humapen savvio (unknown color) was updated to humapen savvio graphite.Narrative and corresponding fields were updated accordingly.Update 18may2017: additional information received on 17may2017 from the global product complaint database.Entered device specific safety summary (dsss).Updated the medwatch fields with device information, the european and canadian (eu/ca) device information.Added date of manufacturer and laboratory values.Corresponding fields and narrative updated accordingly.

Manufacturer Narrative

Narrative field; new updated and corrected information is referenced within the update statements.Please refer to statement dated (b)(6) 2017 in the field.No further follow up is planned.Evaluation summary a female patient reported her humapen savvio device would not release insulin when the needle was inserted in her belly; the device only released insulin when the needle was removed from her skin.During troubleshooting, the patient indicated the device "became very hard to press;" the patient indicated it was "as if something was jamming" the device.The patient experienced hypoglycemic unconsciousness.The device was not returned to the manufacturer for investigation (batch 1503v03, manufactured march 2015).Therefore, it could not be evaluated to confirm the complaint or presence of a malfunction.Malfunction unknown.A complaint history review for the batch did not identify any atypical findings with respect to dose accuracy, leaking after injection, or pen jams.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.The patient reported "she was diabetic and it has been getting to her sight." the 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 and storage.The patient used the device while visually impaired; this may be relevant to the event of hypoglycemic unconsciousness.In addition, the patient reused needles and stored the humapen savvio device in the refrigerator with a needle attached.It is unknown if these are relevant to the event of hypoglycemic unconsciousness.

Event Description

Lilly case id: (b)(6) this spontaneous case, reported by a consumer, who contacted the company to report an adverse event with a product complaint, concerns female patient of unspecified age and ethnicity.Medical history: diabetes since 1987.Concomitant medications: liraglutide for diabetes.The patient received human insulin (rdna origin) nph (humulin n) cartridge and human insulin (rdna origin) regular (humulin r) cartridge, 30 iu each morning and 30 iu each evening (did not specify the dose of each insulin), both via unknown route of administration, for diabetes, starting on an unspecified date.The reporter stated that the patient used insulin since 1999, but did not specify which insulin.In 2010, unclear if prior or after starting both human insulin nph and human insulin regular, the patient experienced visual impairment.On an unspecified date, unspecified time after starting both human insulin nph and human insulin regular therapy via humapen savvio 3ml graphite, the patient experienced a lot of peaks (as reported), some days it was around 400 and 500 and some days it was around 50 (units and normal limits not provided) and the patient was fainting.It was reported that, on unspecified dates, the patient went to the hospital due to it (unclear if the patient was hospitalized).The event of glycaemia around 50 with fainting was considered serious by the company due to medically significant reasons.Information regarding laboratory exams, corrective treatment and outcomes was not reported.The patient had visual impairment, reused needles, stored the in-use pen in refrigerator and stored the pen with the needle attached.As of 12apr2017, it was reported that the device was not working because the insulin was not being released when the patient injected on belly, it was only released when the patient removed the needle of skin, very hard to press, and indicated it was as if something was jamming the device (product complaint number (b)(4) /lot number 1503v03.Human insulin nph and human insulin r therapies status were not reported.The patient operated the device and it was unknown if she was trained.The patient had used this device model for unspecified time and the reported humapen savvio 3ml graphite for less than 15 days.The device was not returned to the manufacturer.The reporting consumer did not provide a relatedness opinion.Update 14apr2017: upon review this case was opened to update the medwatch fields for regulatory reporting.Update 18apr2017: additional information was received on 17apr2017 from the initial reporting consumer.Device humapen savvio (unknown color) was updated to humapen savvio graphite.Narrative and corresponding fields were updated accordingly.Update 18may2017: additional information received on 17may2017 from the global product complaint database.Entered device specific safety summary (dsss).Updated the medwatch fields with device information, the european and canadian (eu/ca) device information.Added date of manufacturer and laboratory values.Corresponding fields and narrative updated accordingly.

• 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: caroline rosewell ; lilly corporate center; indianapolis, IN 46285 ; 3172764376
• MDR Report Key: 6503057
• MDR Text Key: 73116846
• Report Number: 1819470-2017-00074
• 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: 06/14/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/19/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Model Number: MS9698
• Device Lot Number: 1503V03
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 05/17/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 03/31/2015
• 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
• Treatment: HUMULIN INSULIN REGULAR; LIRAGLUTIDE
• Patient Outcome(s): Other