MAUDE Adverse Event Report: ELI LILLY AND COMPANY HUMAPEN LUXURA BURGUNDY; FOR TREATMENT PURPOSES

Model Number MS9662

Device Problems Activation, Positioning or Separation Problem (2906); Physical Resistance/Sticking (4012)

Patient Problems Hyperglycemia (1905); Missed Dose (2561)

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

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 an (b)(6) female patient of unknown origin.Medical history and concomitant medications were not provided.The patient received insulin lispro protamine suspension 50%/insulin lispro 50% (rdna origin) (humalog mix 50, 100 u/ml) from a cartridge via a reusable humapen luxura burgundy, three times a day (morning: 20 u, noon 12 u and night: 20 u) subcutaneously, for the treatment of diabetes mellitus, beginning on an unknown date in 2010 (ten years ago).Since an unknown date she could not hear.The event of could not hear was considered as serious by company due to medically significance.On an unknown date there was the failure of the humapen luxura burgundy injection pen (the injection screw of the insulin injection pen could not move and the injection button could be pushed down, and the protamine suspension 50%/insulin lispro 50% could not flow out ((b)(4)/ lot number 1112b05), which leaded that she was hospitalized on (b)(6) 2020 or on (b)(6) 2020 due to blood glucose high; blood glucose value: 30 (no units values and normal ranges provided), and was discharged on (b)(6) 2020.Due to failure of the injection pen, she did not use insulin lispro mix 50, and used other unspecified brand insulin.At the time of the report; as of (b)(6) 2020, she did not use protamine suspension 50%/insulin lispro 50%.Since an unknown date her whole body was sick, but which diseases were not provided.Information regarding corrective treatment and outcome of the events and status of protamine suspension 50%/insulin lispro 50% was not provided.No additional follow up would be attempted as the reporter requested not to call her to ask these questions, and hung up the phone and hcp contact details were also not provided.The operator of the humapen luxura burgundy device and his/her training status was not provided.The general humapen luxura burgundy device model duration of use and suspect humapen luxura burgundy device duration of use were unknown.The action taken with suspect humapen unknown device and its return status were not provided.The initial reporting consumer did not know if the events were related to insulin lispro mix 50 drug.The initial reporting consumer did not provide relatedness assessment between the events and humapen unknown device but related the event of missed dose and blood glucose increased with product complaint of humapen unknown device.The initial reporting consumer did not provide relatedness assessment between the event of sickness and insulin lispro mix 50 drug and humapen unknown device.Update 21may2020: information received on (b)(6) 2020 from the initial reporter.No medically significant information was received.No changes in case.Upon internal review the narrative was fixed to be chronologically described.Edit 21may2020: updated medwatch and european and (b)(6) (eu/(b)(6)) fields for expedited device reporting.No new information added.Update 29-may-2020: additional information was received from the initial reporting consumer on 26-may-2020.Added one non-serious event of sickness.Added patient age.Updated causality statement and narrative with new information.Update 01jun2020: additional information received on 01jun2020 from global product complaint database.Recoded the humapen unknown body type to a humapen luxura burgundy.Changed the lot number from unknown to 1112b05 for product complaint (b)(4) relating to the humapen luxura burgundy.Updated device return status to returned to manufacturer and added date returned to manufacturer for the suspect device.Corresponding fields and narrative updated accordingly.

Manufacturer Narrative

B.5.Narrative field: new, updated and corrected information is referenced within the update statements in b.5.Please refer to update statement dated 26jun2020 in the b.5.Field.No further follow-up is planned.Evaluation summary: a consumer reported the injection screw of the patient's humapen luxura device did not move, and the injection button could not be pushed down.The patient experienced increased blood glucose.Investigation of the returned device (batch 1112b05, manufactured december 2011) found the device met functional requirements.No malfunction identified.The investigation also found the lens of the device detached and missing, and the front housing thread ends partly tipped.In addition, the cartridge holder printing was partly faded.This damage to the device occurred in the field (not related to the manufacturing process) and did not impact the functionality of the device.The instructions for use provide proper care and storage instructions.While it is unknown how long the patient used the device, based on the amount of time elapsed since the device was manufactured (december 2011), it is likely the patient used it beyond the approved use life.The instructions for use state the humapen luxura device has been designed to be used for up to six years after first use.There is evidence of improper use or storage.The patient likely used the device beyond its approved use life.This is not likely relevant to the event of increased blood glucose since the device met functional requirements.

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 an 85-year-old female patient of unknown origin.Medical history and concomitant medications were not provided.The patient received insulin lispro protamine suspension 50%/insulin lispro 50% (rdna origin) (humalog mix 50, 100 u/ml) from a cartridge via a reusable humapen luxura (burgundy) device, three times a day (morning: 20 u, noon 12 u and night: 20 u) subcutaneously, for the treatment of diabetes mellitus, beginning on an unknown date in 2010 (ten years ago).Since an unknown date she could not hear.The event of could not hear was considered as serious by company due to medically significance.On an unknown date there was the failure of the humapen luxura (burgundy) injection pen; further described, the injection screw of the insulin injection pen could not move and the injection button could be pushed down, and the protamine suspension 50%/insulin lispro 50% could not flow out ((b)(4)/ lot number 1112b05).Which leaded that she was hospitalized on (b)(6) 2020 or on (b)(6) 2020 due to blood glucose high; blood glucose value: 30 (no units values and normal ranges provided), and was discharged on (b)(6) 2020.Due to failure of the injection pen, she did not use insulin lispro mix 50, and used other unspecified brand insulin.At the time of the report; as of (b)(6) 2020, she did not use protamine suspension 50%/insulin lispro 50%.Since an unknown date her whole body was sick, but which diseases were not provided.Information regarding corrective treatment and outcome of the events and status of protamine suspension 50%/insulin lispro 50% was not provided.No additional follow up would be attempted as the reporter requested not to call her to ask these questions, and hung up the phone and hcp contact details were also not provided.The operator of the humapen luxura (burgundy) device and his/her training status was not provided.The general humapen luxura burgundy device model duration of use and suspect humapen luxura burgundy device duration of use were unknown; however, the humapen luxura (burgundy) device with lot number 1112b05 was manufactured december 2011.The suspect humapen luxura (burgundy) device associated with product complaint (b)(4) was returned to the manufacturer on 01jun2020.The initial reporting consumer did not know if the events were related to insulin lispro mix 50 drug.The initial reporting consumer did not provide relatedness assessment between the events and humapen (burgundy) but related the event of missed dose and blood glucose increased with product complaint of humapen (burgundy).The initial reporting consumer did not provide relatedness assessment between the event of sickness and insulin lispro mix 50 drug and humapen (burgundy) device.Update 21may2020: information received on 18may2020 from the initial reporter.No medically significant information was received.No changes in case.Upon internal review the narrative was fixed to be chronologically described.Edit 21may2020: updated medwatch and european and canadian (eu/ca) fields for expedited device reporting.No new information added.Update 29-may-2020: additional information was received from the initial reporting consumer on 26-may-2020.Added one non-serious event of sickness.Added patient age.Updated causality statement and narrative with new information.Update 01jun2020: additional information received on 01jun2020 from global product complaint database.Recoded the humapen unknown body type to a humapen luxura burgundy.Changed the lot number from unknown to 1112b05 for product complaint (b)(4) relating to the humapen luxura burgundy.Updated device return status to returned to manufacturer and added date returned to manufacturer for the suspect device.Corresponding fields and narrative updated accordingly.Update 26jun2020: additional information received on 26jun2020 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, improper use and storage from no to yes and malfunction from unknown to no.Added date of manufacturer for the returned suspect humapen luxura burgundy device associated with product complaint (b)(4).Corresponding fields and narrative updated accordingly.Update 02-jul-2020: information was received from affiliate on 01-jul-2020 regarding unsuccessful follow up attempt.No medical significant information was received in the case.Update 02jul2020: additional information received on 02jul2020 from the global product complaint database.No new information added.

• Brand Name: HUMAPEN LUXURA BURGUNDY
• Type of Device: FOR TREATMENT PURPOSES
• Manufacturer (Section D): ELI LILLY AND COMPANY; lilly corporate center; indianapolis, in
• MDR Report Key: 10115322
• MDR Text Key: 200976049
• Report Number: 1819470-2020-00059
• Device Sequence Number: 1
• Product Code: FMF
• Combination Product (y/n): N
• PMA/PMN Number: K142518
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer,foreign
• Type of Report: Initial,Followup
• Report Date: 07/07/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Other
• Device Model Number: MS9662
• Device Lot Number: 1112B05
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 06/01/2020
• Initial Date Manufacturer Received: 05/18/2020
• Initial Date FDA Received: 06/03/2020
• Supplement Dates Manufacturer Received: 06/26/2020
• Supplement Dates FDA Received: 07/07/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization
• Patient Age: 85 YR
• Patient Weight: 60