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

Model Number MS9694

Device Problems Difficult to Insert (1316); Device Difficult to Setup or Prepare (1487)

Patient Problems Hyperglycemia (1905); Retinal Detachment (2047); Blurred Vision (2137)

Event Date 01/01/2016

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.

Event Description

(b)(4).This report is associated with product compliant: pending.This spontaneous case reported by a consumer who contacted the company to report an adverse event and a product complaint, concerns a female patient of unknown age and origin.Medical history and concomitant medications were not provided.The patient received insulin lispro (humalog), cartridge and also human insulin (rdna origin) nph (humulin n), unknown formulation; both unknown dose, frequency, route of administration, indication for use and start date.On an unknown date, unknown time after beginning treatment with insulin lispro via humapen unknown device (unknown lot number), humapen savvio red (lot number 1403v04) or humapen luxura champagne (lot number 1210b02), (not specified which device the patient was using in the occasion) and human insulin nph via syringe, the cartridge of insulin was not entering the device and, due to this, the glycaemia of the patient went to 700 (units and reference range not provided) and the patient almost entered in a coma, which was considered serious by the company due to medically significant reasons.Information regarding corrective treatment and outcome for this event was not provided.Moreover, it was also provided that since an unknown date, the retina of the patient detached, which was also considered serious by the company due to medically significant reasons and also that the patient had three grades of hypermetropia in the other eye.Information regarding corrective treatment and outcome for these events was not provided.It was also provided that in apr2017, the patient underwent an unspecified eye surgery; however, no additional information was provided.Insulin lispro and human insulin nph treatment continued.The patient was the operator of the devices and it was unknown if she was trained.It was also unknown how long the device models, the humapen unknown device and humapen luxura champagne (1210b02) were used and the humapen savvio red (1403v04) was used for two years.The return status of humapen savvio red and humapen luxura champagne was not provided and the humapen unknown device was discarded; therefore, the return was not expected.The reporting consumer did not provide any opinion of relatedness.This case is cross-referenced with the following case (b)(4).Update 11may2017: updated medwatch and european and canadian (eu/ca) fields for the humapen savvio red, humapen luxura champagne, and the humapen unknown device.

Manufacturer Narrative

No further follow-up is planned.This report is associated with 1819470-2017-00086 and 1819470-2017-00088 , since there is more than one device implicated.Evaluation summary: a female patient reported that she had difficulty attaching the cartridge holder with insulin to her humapen savvio device.When she attempted to apply insulin, the cartridge holder was loose and no insulin was applied.In addition, the patient reported that the injection screw of the device 'fell' and she lost it.The patient experienced increased blood glucose.Investigation of the returned device (batch (b)(4), manufactured march 2014) found that the device met functional requirements and met dose accuracy and glide (injection) force specifications.The cartridge holder attached normally, and the injection screw appeared normal and functioned normally.No malfunction was identified.The patient reported that she has a problem with 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.In addition, by design, the injection screw of the pen is not locked in position if the cartridge holder is not attached.This may explain the patient's perception that the injection screw fell and she lost it.The instructions for use provide directions for inserting a cartridge and attaching the cartridge holder securely to the pen body.The instructions for use further state, "the screw may not move out when you push the injection button unless there is a cartridge in the pen.Once a cartridge is inserted, then the screw will move out when the injection button is pushed." there is evidence of improper use.The patient used the device while visually impaired.This may be relevant to the event of increased blood glucose and the complaint of cartridge holder attachment issues.

Event Description

Lilly case id: (b)(4).This report is associated with product compliant: (b)(4).This spontaneous case reported by a consumer who contacted the company to report an adverse event and a product complaint, concerns a female patient of unknown age and origin.Medical history and concomitant medications were not provided.The patient received insulin lispro (humalog), cartridge and also human insulin (rdna origin) nph (humulin n), unknown formulation; both unknown dose, frequency, route of administration, indication for use and start date.On an unknown date, unknown time after beginning treatment with insulin lispro via humapen unknown device (unknown lot number), humapen savvio red (lot number 1403v04) or humapen luxura champagne (lot number 1210b02), (not specified which device the patient was using in the occasion) and human insulin nph via syringe, the cartridge of insulin was not entering the device and, due to this, the glycaemia of the patient went to 700 (units and reference range not provided) and the patient almost entered in a coma, which was considered serious by the company due to medically significant reasons.Information regarding corrective treatment and outcome for this event was not provided.Moreover, it was also provided that since an unknown date, the retina of the patient detached, which was also considered serious by the company due to medically significant reasons and also that the patient had three grades of hypermetropia in the other eye.Information regarding corrective treatment and outcome for these events was not provided.It was also provided that in (b)(6) 2017, the patient underwent an unspecified eye surgery; however, no additional information was provided.Insulin lispro and human insulin nph treatment continued.The patient was the operator of the devices and it was unknown if she was trained.It was also unknown how long the device models, the humapen unknown device and humapen luxura champagne (1210b02) were used and the humapen savvio red (1403v04) was used for two years.The return status of humapen savvio red and humapen luxura champagne was not provided and the humapen unknown device was discarded; therefore, the return was not expected.The reporting consumer did not provide any opinion of relatedness.This case is cross-referenced with the following case (b)(4).Update 11may2017: updated medwatch and (b)(4) fields for the humapen savvio red, humapen luxura champagne, and the humapen unknown device.Update 05jun2017: additional information was received on 02jun2017 from initial reporter consumer.Updated suspect humapen unknown device (unknown lot) to humapen savvio red (unknown lot); added onset date of blood glucose increased event; added reporter consumer did not know which device the patient was using in the occasion; added non-serious event of drug dose omission; updated relatedness paragraph.Narrative and correspondent fields were updated accordingly.Update 22jun2017: additional information received on 20jun2017 and 21jun2017 from the global product complaint database were processed together.Entered device specific safety summary (dsss); updated the medwatch fields and the (b)(4) device information; improper use and storage from no to yes for the suspect humapen savvio red relating to (b)(4).Updated the return status to returned to the manufacturer for the humapen savvio red and humapen luxura champagne relating to product complaints (b)(4) and (b)(4) respectively.Corresponding fields and narrative updated accordingly.Update 11jul2017: additional information received on 11jul2017 from the global product complaint database.Entered device specific safety summary (dsss), updated the medwatch fields and the (b)(4) device information, improper use and storage from no to yes and malfunction from unknown to no, and added date of manufactured for the devices associated with (b)(4) and (b)(4).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
• 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: 6615690
• MDR Text Key: 76792824
• Report Number: 1819470-2017-00087
• 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: 08/09/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/06/2017
• 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?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/01/2017
• Date Manufacturer Received: 07/11/2017
• Was Device Evaluated by Manufacturer?: Yes
• 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: HUMAN INSULIN NPH; LISPRO
• Patient Outcome(s): Other