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

Model Number MS9694

Device Problem Mechanical Jam (2983)

Patient Problems Cataract (1766); Hearing Loss (1882); Hypoglycemia (1912); Memory Loss/Impairment (1958); Blurred Vision (2137); Coma (2417)

Event Date 01/31/2016

Event Type  Injury  

Manufacturer Narrative

Narrative field; new updated and corrected information is referenced within the update statements.Please refer to statement dated 19apr2016 in the narrative field.There are 2 devices implicated this is associated with lot 1403v04.This report is associated with 1819470-2016-000179 and 1819470-2016-00093, since there is more than one device implicated.Evaluation summary: a female patient reported her humapen savvio device was jammed and insulin would not come out.She experienced a serious adverse event of hypoglycemic coma and a non-serious adverse event of increased blood glucose, although neither event was related to the complaint.The device was not returned for investigation (batch (b)(4), manufactured march 2014).Therefore, it could not be evaluated to confirm the complaint or presence of a malfunction.Malfunction unknown.A complaint history review of this batch did not identify any atypical trends with regard to pen jammed and dose accuracy.All humapen savvio devices are assessed for injection screw travel at the end of the manufacturing process, thus ensuring device functionality and dose accuracy.The call center was able to resolve the complaint by having the patient attach a new needle to the device and then releasing the insulin.There is no evidence of improper use or storage.

Event Description

(b)(4).This spontaneous case, reported by a consumer, who contact the company to report and product complaint and an adverse event, concerns a female patient of unknown origin, born on (b)(6).Medical history included rheumatism since she was (b)(6), strong pain on the knee; diabetes type ii, arthritis, arthrosis, osteoporosis (bones were crumbling), clogged vein on the heart and crooked toes due to rheumatism and because of that, she wore wheelchair.Concomitant medication included carvedilol for heart; calcium carbonate + cholecalciferol and cholecalciferol for rheumatism and bones; levothyroxine sodium for thyroid and simvastatin for unknown indication.The patient received human insulin (rdna) nph (humulin n) cartridge, 22 iu in the morning, 14 iu in the afternoon; conflicting information also reported as 20 iu in the morning and 12 iu in the afternoon; and human insulin (rdna) regular (humulin r) cartridge, 6 iu in the morning and 4 iu in the afternoon, both daily, subcutaneously, indicated for diabetes, since an unspecified date, reported as long time ago.It was provided the patient received human insulin nph and regular via humapen luxura hd and humapen savvio and had a third unspecified lilly device color blue, unknown batch number.The patient had been using the devices since starting insulin treatment.Since an unspecified date, unknown time after starting treatment with human insulin nph and human insulin regular, and unknown if via humapen luxura hd, humapen savvio or unspecified lilly device color blue, the patient had been experiencing difficulty hearing.As a corrective measure, the patient wore a hearing aid device, but did not recover of the event.On an unspecified date, the patient experienced cataract.As corrective treatment in 2011, she underwent to a surgery and recovered of cataract and could see very well.The event of cataract was considered serious and medically significant by the company.Nevertheless, it was provided that occasionally the patient experienced blurred vision due to diabetes, when her glycaemia was high; usually around 200, 300 never lower than 150 (units and range not provided).The patient did not receive any corrective treatment for blurred vision and did not recover of it.It was unknown if the patient received any corrective treatment for glycaemia was high and the outcome was not provided.Additionally, the initial reporter consumer stated the patient had already entered in coma four or five times (also reported as more than two times) due to lack of food, since the patient did not eat overnight and her glycaemia dropped down.It was also stated by the reporter that the patient was not sure if she was in use of unspecified lilly device color blue when the comas occurred and that maybe she had changed to another pen.When that happened, a help mobile went to the patient s home and administered glucose into her vein and she was recovered.The event of coma was considered serious and medically significant by the company.Approximately since 2014, the patient started forgetting things.The reporter consumer stated that according to the physician, the patient was forgetting things because of a clogged vein on the neck.Due to that on (b)(6) 2016, she underwent to an unspecified surgical procedure to unclog this vein.It was unknown if the patient received any corrective treatment for the event of patient started forgetting things.The outcome of these events was not provided.The event of clogged vein on the neck was considered serious and medically significant by the company.Furthermore, on unspecified date the patient noticed the humapen luxura hd, batch number (lot 1210g01/(b)(4)) and humapen savvio (lot 1403v04/(b)(4)) were not working, because it was jammed and the insulin was not coming out.No adverse event was reported due to the device problem.The patient did not reuse needles and stored the pen at room temperature.In (b)(6) 2016, the patient experienced another coma and at this time her glycaemia was at 23 (units and range not provided).It was reported the patient s last meal had been around 8 p.M.And the coma happened about 4h or 4h30 a.M.The reporter stated the patient did not realize when she got in coma and that the help mobile was again called to measure her glycaemia and receive glucose.The outcome of the event of coma with glycaemia at 23 was not provided.It was also provided the physician always requested exams, but the patient could not do it, because her glycaemia was always very low and she had to eat something and exams needed fasting.The outcome of the event glycaemia was always very low was not provided.Additionally, between (b)(6) 2016, the patient got flu with catarrh in the throat and nose and she was also presenting cough.No information regarding corrective treatment was provided for the events of flu and cough, and the outcome was unknown.As of 04jul2016, it was reported the patient had been using the unspecified lilly device color blue with human insulin nph and that the numbers had been erased, but it was still possible to use it ((b)(4)).The treatment with human insulin nph and regular were continued.The patient operated the devices and she was a trained user.It was provided that both devices were new and had been used for a short time.Humapen savvio 1403v04 will not return.Usage concerns resolved and device was reported to be working properly.Humapen luxura hd was not returned therefore an evaluation was not possible.The third unspecified lilly device color blue had been used for a long time (unspecified) and its return is not expected.The reporting consumer related the events of cataract, blurred vision; glycaemia was high, difficulty hearing, heart problem, and coma (first episode) to human insulin nph and regular treatment.No other relatedness opinion was provided.(b)(4).Update 07apr2016: upon review, this case was opened to complete the medwatch fields for regulatory reporting.Edit 12apr2016: case unlocked to add product complaint number only.Update 19apr2016.Additional information received on 18apr2016 from the product complaint safety database.To the device tabs added manufacture dates, the device specific safety summaries (dsss), updated the european and canadian (eu/ca) device information, updated the medwatch device information and the narrative was updated accordingly.Update 06jul2016: additional information received on 04jul2016 from the initial reporter consumer and on 05jul2016 from the customer service was processed.Added diabetes type ii, arthritis, arthrosis, osteoporosis, clogged vein and unspecified procedure to unclog vein to medical history; deleted the event reported as heart problem and added to medical history as cardiac insufficiency; onset treatment; non-serious event of glycaemia was always very low; conflicting information regarding human insulin nph dosage; non-serious event of flu; non-serious event of cough; serious event of coma with glycaemia at 23 (second episode); third lilly device blue color as suspect (coded as ergo unknown body type) and product compliant; updated device paragraph and causality opinion; added information patient had been using the devices since starting insulin treatment.Narrative rearranged.Regenerated psur comment.Updated narrative and fields with new information accordingly.Edit 06jul2016: the event of patient was forgetting things was downgraded to non-serious and the corrective treatment was updated from yes to unknown; the event of clogged vein on the neck, which had already been outlined in the narrative, was coded in the tab as a serious adverse event.Update 07jul2016: upon review, this case was opened to update the medwatch fields for regulatory reporting.Update 11jul2016: case unlocked to add product complaint number only.Update 14jul2016: additional information received from initial reporting consumer on 13jul2016.Changed the onset time of difficulty hearing event to include all suspect drugs and devices.Added information about the use of unspecified lilly device color blue when the event of hypoglycemic coma occurred.Recoded the device ergo, unknown body type to humapen, unknown device, and updated eu/ca fields.Narrative and corresponding fields were 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
• 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: 5811637
• MDR Text Key: 50077878
• Report Number: 1819470-2016-00178
• 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
• Report Date: 03/31/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/21/2016
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Model Number: MS9694
• Device Lot Number: 1403V04
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 07/04/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 03/31/2014
• 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
• Treatment: PURAN T4
• Patient Outcome(s): Other
• Patient Age: 78 YR