MAUDE Adverse Event Report: ELI LILLY AND COMPANY HUMAPEN, UNKNOWN DEVICE; FOR TREATMENT PURPOSES

Model Number UNKNOWN

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

Patient Problems Abrasion (1689); Hearing Impairment (1881); Tinnitus (2103)

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 1819470-2020-00064 since there is more than one device implicated.

Event Description

Lilly case id: (b)(4).This report is associated with product complaint: (b)(4).This spontaneous case, reported by a consumer who contacted the company to report adverse events and product complaint, concerned a (b)(6) years-old female patient of (b)(6) origin.Medical history included nerve pathological change.Concomitant medications included acarbose for the treatment of nerve pathological changes.The patient received insulin lispro protamine suspension 75%/insulin lispro 25% (rdna origin) (humalog mix 25, 100 u/ml) from a cartridge via a reusable humapen (unknown device), twice a day (morning:14, night: 16) subcutaneously for the treatment of diabetes mellitus from about 2005 (had used for 14 or 15 years, and the specific time was uncertain).On an unknown date the humapen unknown device injection screw could not move, and the injection button was pushed down to the end directly, but no medicine liquid flowed out (b)(4), lot unknown).On an unknown date after starting insulin lispro mix 25, she had bad ears/hearing was bad (tinnitus) and eye retina had lesion /retinopathy (patient was the operator of the devices- improper use of the devices).On an unknown date around 2017, she started to inject insulin lispro mix 25 via humapen ergo ii (blue, plastic) reusable device.On (b)(6) 2020, the humapen injection (blue, plastic) screw could not move, and the injection button was pushed down to the end directly, but no medicine liquid flowed out.And new needle was changed each time, but the injection was not smooth before.Due to humapen ego ii problem, she did not inject insulin since night on (b)(6) 2020 to (b)(6) 2020 (now) (b)(4), lot 1404d01).On an unknown dates there were two times of hospitalization for blood glucose regulation due to poor blood glucose control after the use of insulin lispro mix 25 (specific time of hospitalization was not provided).She would eat acarbose occasionally when she had emotions, one for each meal.Information regarding corrective treatment and outcome of the events and status of insulin lispro mix 25 therapy was not provided.The patient was operator of the reusable humapen unknown device and humapen ergo ii devices and her training status was not provided.The general reusable humapen unknown device model duration of use and suspect reusable device duration of use was unknown.The general reusable humapen ergo ii device model duration of use and suspect humapen ergo ii reusable device duration of use was unknown but it started about 2017.The action taken with both suspect reusable humapen unknown device and humapen ergo ii device was unknown.The status of suspect reusable humapen unknown device and humapen ergo ii device was unknown and their return status was not provided.The initial reporting consumer did not know if the events were related to insulin lispro mix 25 drug.The initial reporting consumer did not provide relatedness assessment between the events and humapen unknown device and humapen ergo ii device but related the event of missed dose with product complaint of humapen ergo ii device.Update 21-may-2020: the information received on 15-may-2020 and 15-may-2020 was processed together.Edit 21may2020: updated medwatch and (b)(6) fields for expedited device reporting.No new information added.

Manufacturer Narrative

B.5.Narrative field; new updated and corrected information is referenced within the update statements in b.5.Please refer to statement dated 04jun2020 in the b.5.Field.No further follow up is planned.This report is associated with 1819470-2020-00064 since there is more than one device implicated.Evaluation summary a female patient reported that, on an unknown date, her humapen (unknown device type) "injection screw could not move, and the injection button was pushed down to the end directly, but no medicine liquid flowed out." on an unknown date, she experienced abnormal blood glucose.The device was not returned to the manufacturer for investigation (batch number unknown).Therefore, it could not be evaluated to confirm the complaint or presence of a malfunction.Malfunction unknown.All humapen devices are assessed for injection screw travel at the end of the manufacturing process, thus ensuring device functionality with high probability.The patient reported visual impairment.The core instructions for use states that the device is not recommended for 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 the misuse is relevant to the event of abnormal blood glucose.

Event Description

Lilly case id: cn (b)(4).This report is associated with product complaint: (b)(4).This spontaneous case, reported by a consumer who contacted the company to report adverse events and product complaint, concerned a 79-years-old female patient of asian (han) origin.Medical history included nerve pathological change.Concomitant medications included acarbose for the treatment of nerve pathological changes.The patient received insulin lispro protamine suspension 75%/insulin lispro 25% (rdna origin) (humalog mix 25, 100 u/ml) from a cartridge via a reusable humapen (unknown device), twice a day (morning:14, night: 16) subcutaneously for the treatment of diabetes mellitus from about 2005 (had used for 14 or 15 years, and the specific time was uncertain).On an unknown date the humapen unknown device injection screw could not move, and the injection button was pushed down to the end directly, but no medicine liquid flowed out (pc 5152039, lot unknown).On an unknown date after starting insulin lispro mix 25, she had bad ears/hearing was bad (tinnitus) and eye retina had lesion /retinopathy (patient was the operator of the devices- improper use of the devices).On an unknown date around 2017, she started to inject insulin lispro mix 25 via humapen ergo ii (blue, plastic) reusable device.On 14-may-2020, the humapen injection (blue, plastic) screw could not move, and the injection button was pushed down to the end directly, but no medicine liquid flowed out.And new needle was changed each time, but the injection was not smooth before.Due to humapen ego ii problem, she did not inject insulin since night on 14-may-2020 to 15-may-2020 (now) (pc 5152040, lot 1404d01).On an unknown dates there were two times of hospitalization for blood glucose regulation due to poor blood glucose control after the use of insulin lispro mix 25 (specific time of hospitalization was not provided).She would eat acarbose occasionally when she had emotions, one for each meal.Information regarding corrective treatment and outcome of the events and status of insulin lispro mix 25 therapy was not provided.The patient was operator of the reusable humapen unknown device and humapen ergo ii devices and her training status was not provided.The general reusable humapen unknown device model duration of use and suspect reusable device duration of use was unknown.The general reusable humapen ergo ii device model duration of use and suspect humapen ergo ii reusable device duration of use was unknown but it started about 2017.The action taken with both suspect reusable humapen unknown device and humapen ergo ii device was unknown.The status of suspect reusable humapen unknown device and humapen ergo ii device was unknown and their return status was not provided.The initial reporting consumer did not know if the events were related to insulin lispro mix 25 drug.The initial reporting consumer did not provide relatedness assessment between the events and humapen unknown device and humapen ergo ii device but related the event of missed dose with product complaint of humapen ergo ii device.Update 21-may-2020: the information received on 15-may-2020 and 15-may-2020 was processed together.Edit 21may2020: updated medwatch and european and canadian (eu/ca) fields for expedited device reporting.No new information added.Update 04jun2020: additional information received on 04jun2020 from the global product complaint database.Entered the device specific safety summary (dsss) and updated the medwatch and european and canadian (eu/ca) device fields for the suspect devices associated with pc (b)(4) and (b)(4).Added the date of manufacture for the suspect humapen ergo ii device associated with pc (b)(4).Corresponding fields and narrative updated accordingly.Update 05jun2020: additional information received on 05jun2020 from the global product complaint database.No new information was added.

• Brand Name: HUMAPEN, UNKNOWN DEVICE
• Type of Device: FOR TREATMENT PURPOSES
• Manufacturer (Section D): ELI LILLY AND COMPANY; lilly corporate center; indianapolis, in
• MDR Report Key: 10096932
• MDR Text Key: 195418300
• Report Number: 1819470-2020-00063
• Device Sequence Number: 1
• Product Code: FMF
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer,foreign
• Type of Report: Initial,Followup
• Report Date: 06/10/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/28/2020
• Is this an Adverse Event Report?: Yes
• Device Operator: Lay User/Patient
• Device Model Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 06/04/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization
• Patient Age: 79 YR
• Patient Weight: 54