MAUDE Adverse Event Report: ELI LILLY AND COMPANY HP LUXURA, UNKNOWN PEN BODY TYPE; FOR TREATMENT PURPOSES

Model Number UNKNOWN

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Hypoglycemia (1912); Loss of Vision (2139)

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 compliant: (b)(4).This spontaneous case, reported by a consumer who contacted the company to report adverse events and a product complaint (pc), concerned an (b)(6) male patient of an unknown origin.Medical history included intestinal/colon cancer, three bypasses and cardiac surgery.Concomitant medications were not provided.The patient received insulin lispro (rdna origin) (humalog) and human insulin (rdna origin) (huminsulin) from a cartridge via a reusable pen humapen luxura (unknown body type) at an unknown dose and frequency subcutaneously for the treatment of type 2 diabetes mellitus (dm ii), beginning sometime in beginning of 1960.Sometime in 2015, while on insulin lispro and human insulin treatment, he became blind and could see 0.01% on one eye and only light and dark shades from other eye.The event blindness was considered as serious due to medical significance reason.On an unknown date, he was hospitalized and developed hypoglycemia (values, units and reference range not provided) since the nursing staff was unable to control blood glucose values.He used parallel import cartridges which did not fit into his hp luxura pen and his new batch matches fit (pc# for insulin lispro drug (b)(4), lot# unknown) (pc# for human insulin drug (b)(4), lot# unknown) and (pc# for hp luxura pen (b)(4), lot# unknown).Information regarding hospitalization details, corrective treatment, outcome of the events and status of insulin lispro and human insulin treatment was not provided.Follow up would not be requested as reporter did not provide consent to be contacted and healthcare professional.The patient was the operator of the hp luxura pen and his training status was not provided.The device model duration of use and suspect device duration were not reported.The action taken with hp luxura pen and its return status was not provided.The reporting consumer did not provide any opinion on relatedness between the events and insulin lispro, human insulin and hp luxura pen.Edit 03dec2018: updated medwatch and european and canadian (eu/ca) fields for expedited device reporting.No new information added.Edit 06-dec-2018: upon review of information received on 12-nov-2018, updated coding of humapen luxura as humapen luxura (unknown body type) from humapen luxura (burgundy color).

Event Description

Lilly case id: (b)(4).This spontaneous case, reported by a consumer who contacted the company to report adverse events and a product complaint (pc), concerned an 83-year-old male patient of an unknown origin.Medical history included intestinal/colon cancer, three bypasses and cardiac surgery.Concomitant medications were not provided.The patient received insulin lispro (rdna origin) (humalog) and human insulin (rdna origin) (huminsulin) from a cartridge via a reusable pen humapen luxura (unknown body type) at an unknown dose and frequency subcutaneously for the treatment of type 2 diabetes mellitus (dm ii), beginning sometime in beginning of 1960.Sometime in 2015, while on insulin lispro and human insulin treatment, he became blind and could see 0.01% on one eye and only light and dark shades from other eye.The event blindness was considered as serious due to medical significance reason.On an unknown date, he was hospitalized and developed hypoglycemia (values, units and reference range not provided) since the nursing staff was unable to control blood glucose values.He used parallel import cartridges which did not fit into his hp luxura pen and his new batch matches fit (pc# for insulin lispro drug (b)(4).Lot# unknown) (pc# for human insulin drug (b)(4).Lot# unknown) and (pc# for hp luxura pen (b)(4).Lot# unknown).Information regarding hospitalization details, corrective treatment, outcome of the events and status of insulin lispro and human insulin treatment was not provided.Follow up would not be requested as reporter did not provide consent to be contacted and healthcare professional.The patient was the operator of the hp luxura pen and his training status was not provided.The device model duration of use and suspect device duration were not reported.The humapen luxura was not returned to the manufacturer.The reporting consumer did not provide any opinion on relatedness between the events and insulin lispro, human insulin and hp luxura pen.Edit 03dec2018: updated medwatch and european and canadian (eu/ca) fields for expedited device reporting.No new information added.Edit 06-dec-2018: upon review of information received on 12-nov-2018, updated coding of humapen luxura as humapen luxura (unknown body type) from humapen luxura (burgundy color).Update 13dec2018: additional information received on 13dec2018 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, improper use and storage from no to yes for the suspect device associated with(b)(4).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 statement dated 13dec2018 in the b.5.Field.No further follow up is planned.Evaluation summary a male patient stated that parallel imported insulin cartridges he received did not fit into his humapen luxura device.He experienced hypoglycemia.The device was not returned for investigation (batch unknown) and no cartridges were returned for examination.Therefore, it could not be evaluated to confirm the complaint or presence of a malfunction.Malfunction unknown.The patient also reported being blind.The core instructions for use state that the device is not recommended for the blind or the visually impaired without the assistance of a sighted individual trained to use the device.The core instructions for use also state that the humapen luxura is for use only with lilly 3 ml insulin cartridges (100 iu/ml or units/ml) and to not use other brands of insulin cartridges.There is evidence of improper use.The patient used the device while visually impaired.It is unknown if this is relevant to the event of hypoglycemia or related to the complaint of cartridges not fitting into his device.

• Brand Name: HP LUXURA, UNKNOWN PEN BODY TYPE
• Type of Device: FOR TREATMENT PURPOSES
• Manufacturer (Section D): ELI LILLY AND COMPANY; lilly corporate center; indianapolis IN 46285
• MDR Report Key: 8154875
• MDR Text Key: 130042661
• Report Number: 1819470-2018-00210
• 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: 01/10/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/12/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Model Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 12/13/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization
• Patient Age: 83 YR