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

Model Number MS9698

Device Problems Device Operates Differently Than Expected (2913); No Flow (2991); Therapeutic or Diagnostic Output Failure (3023)

Patient Problems Hyperglycemia (1905); Discomfort (2330)

Event Date 11/30/2016

Event Type  Injury  

Manufacturer Narrative

This is an initial report.A follow-up report will be submitted when the final evaluation is completed.This report is associated with 1819470-2016-00334, since there is more than one device implicated.

Event Description

(b)(4).This spontaneous case, reported by a consumer who contacted the company to report an adverse event and a product complain, with additional information provided by the initial reporter consumer via patient support program (psp), concerns a (b)(6) brown female patient.Medical history and concomitant medication were not reported.The patient received human insulin (rdna origin) nph (humulin n) cartridge, via reusable pen, 4iu in the morning, 12iu at lunch and dinner and human insulin (rdna origin) regular (humulin r), cartridge, via reusable pen, 32iu in the morning, 4iu at lunch and dinner and 15iu before sleeping, subcutaneously, for diabetes, beginning on an unspecified date.On unknown date in (b)(6) 2016, unknown time after beginning human insulin nph and human insulin regular, while receiving via humapen savvio graphite (lot: 1404v11) and humapen savvio gray (lot: 1406v06), both pens (lot: 1404v11 and lot: 1406v06) had problems and patient felt unwell as she thought they were applying the medication and they were not.In (b)(6) 2016 both pens (lot: 1404v11 and lot: 1406v06) were not applying the medication as the medication did not come out, due to this, patient was hospitalized because her glycaemia reached 477 (no units and normal ranges were provided).As corrective treatment for glycaemia reached 477 patient received unspecified insulin to control the glycaemia and was discharged at the same day.On (b)(6) 2016 patient was recovered from the event of glycaemia reached 477.No other information about exams, corrective treatment and outcome was provided.It was also reported that the patient never made the preparation before the injections, did not reuse the needles, stored the pens at room temperature and the refills (unknown if the in-use or not) in the refrigerator.On (b)(6) 2016 human insulin nph and human insulin regular were ongoing.The patient operated the devices and was trained by a company representative.The patient had used the reported humapen savvio graphite (lot: 1404v11) and humapen savvio gray (lot: 1406v06) and these devices models for unknown time.Return status of the devices was not expected.The consumer reporter did not relate the event of glycaemia reached 477 to human insulin nph and human insulin regular.However related the event of glycaemia reached 477 to the fact that the patient did not know how to handle the pen correctly as she did not know that the cursor had to touch the plunger.No other relatedness opinion was provided.Update 12dec2016: additional information received from initial reporting consumer via psp.Case was initially processed as non valid due to no product.Upon follow up received on 09dec2016 case became valid and serious.Added patients age and ethnicity.Added human insulin nph and human insulin regular as suspect drugs, added humapen savvio graphite (lot: 1404v11) and humapen savvio gray (lot: 1406v06) as suspected devices.Added non serious event of drug dose omission and added serious event of blood glucose increased.Added information about corrective treatment for the event of glycaemia reached 477.Added device details.Updated initial reporting consumer relatedness opinion.Update narrative and corresponding fields accordingly.Update 14dec2016: upon review, the case was opened to update the medwatch fields for regulatory reporting.

Manufacturer Narrative

Narrative field - new, updated and corrected information is referenced within the update statements in describe event or problem.Please refer to update statement dated 21dec2016 in describe event or problem.No further follow up is planned.This report is associated with 1819470-2016-00334, since there is more than one device implicated.Evaluation summary: a female patient reported that her humapen savvio device was not applying medication.The patient experienced increased blood glucose levels.The device was not returned to the manufacturer for investigation (batch (b)(4), manufactured april 2014).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.Troubleshooting was performed by with guidance of a trained professional, attaching a new needle to the device.The insulin was then released normally.There is evidence of improper use.The patient did not prime the device before use.This may be relevant to the event of increased blood glucose levels.

Event Description

(b)(4).This spontaneous case, reported by a consumer who contacted the company to report an adverse event and a product complain, with additional information provided by the initial reporter consumer via patient support program (psp), concerns a (b)(6)female patient.Medical history and concomitant medication were not reported.The patient received human insulin (rdna origin) nph (humulin n) cartridge, via reusable pen, 4iu in the morning, 12iu at lunch and dinner and human insulin (rdna origin) regular (humulin r), cartridge, via reusable pen, 32iu in the morning, 4iu at lunch and dinner and 15iu before sleeping, subcutaneously, for diabetes, beginning on an unspecified date.On unknown date in (b)(6) 2016, unknown time after beginning human insulin nph and human insulin regular, while receiving via humapen savvio graphite (lot: 1404v11;(b)(4)) and humapen savvio gray (lot: 1406v06;(b)(4)), both pens (lot: 1404v11 and lot: 1406v06) had problems and patient felt unwell as she thought they were applying the medication and they were not.In (b)(6) 2016 both pens (lot: 1404v11 and lot: 1406v06) were not applying the medication as the medication did not come out, due to this, patient was hospitalized because her glycaemia reached 477 (no units and normal ranges were provided).As corrective treatment for glycaemia reached 477 patient received unspecified insulin to control the glycaemia and was discharged at the same day.On (b)(6) 2016 patient was recovered from the event of glycaemia reached 477.No other information about exams, corrective treatment and outcome was provided.It was also reported that the patient never made the preparation before the injections, did not reuse the needles, stored the pens at room temperature and the refills (unknown if the in-use or not) in the refrigerator.On (b)(6) 2016 human insulin nph and human insulin regular were ongoing.The patient operated the devices and was trained by a company representative.The patient had used the reported humapen savvio graphite (lot: 1404v11) and humapen savvio gray (lot: 1406v06) and these devices models for unknown time.The devices were not returned.The consumer reporter did not relate the event of glycaemia reached 477 to human insulin nph and human insulin regular.However related the event of glycaemia reached 477 to the fact that the patient did not know how to handle the pen correctly as she did not know that the cursor had to touch the plunger.No other relatedness opinion was provided.Update 12dec2016: additional information received from initial reporting consumer via psp.Case was initially processed as non valid due to no product.Upon follow up received on 09dec2016 case became valid and serious.Added patients age and ethnicity.Added human insulin nph and human insulin regular as suspect drugs, added humapen savvio graphite (lot: 1404v11) and humapen savvio gray (lot: 1406v06) as suspected devices.Added non serious event of drug dose omission and added serious event of blood glucose increased.Added information about corrective treatment for the event of glycaemia reached 477.Added device details.Updated initial reporting consumer relatedness opinion.Update narrative and corresponding fields accordingly.Update 14dec2016: upon review, the case was opened to update the medwatch fields for regulatory reporting.Edit 16dec2016: case unlocked to add product complaint number in narrative.Update 21dec2016: additional information received on 21dec2016 from the global product complaint database added for both devices the device specific safety summary and manufactured date of the device; added the devices were not returned; updated the medwatch and european and canadian required device reporting elements and updated the narrative.

• 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: 6180740
• MDR Text Key: 62603475
• Report Number: 1819470-2016-00333
• 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: company representative,consum
• Type of Report: Initial,Followup
• Report Date: 01/13/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/16/2016
• 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: 1404V11
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 12/21/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 04/30/2014
• 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
• Treatment: HUMULIN NPH; HUMULIN REGULAR
• Patient Outcome(s): Hospitalization
• Patient Age: 21 YR
• Patient Weight: 44