MAUDE Adverse Event Report: ELI LILLY AND COMPANY HUMAPEN LUXURA HALF-DOSE PEN; FOR TREATMENT PURPOSES

Model Number MS9673A

Device Problems Use of Device Problem (1670); Mechanical Jam (2983)

Patient Problems Hypoglycemia (1912); Pain (1994); Swelling (2091); Coma (2417)

Event Date 08/10/2020

Event Type  Injury  

Manufacturer Narrative

If device is returned, evaluation will be performed to determine if a malfunction has occurred.A follow-up report will be submitted when the final evaluation is completed as necessary.

Event Description

Lilly case id: (b)(4).This report is associated with product complaint: (b)(4).This solicited case, reported by a consumer via patient support program (psp), concerned a (b)(6)-year-old (at the time of initial report) female patient of unknown origin.Medical history and concomitant medications were not provided.The patient received insulin lispro (rdna origin) injections (humalog, 100 iu/ml) from a cartridge via a reusable humapen luxura half dose, with unknown dose and frequency, subcutaneously, for the treatment of diabetes mellitus, beginning on an unknown date 2015 (five years ago).Since a long time around (b)(6) 2020 (five-seven months) she had been suffering from swelling in her leg associated with dry skin and bluish color at the site of injection, one leg was different than the other as she always took her insulin usually in one place as it was more comfortable for her and did not cause pain for her.She had been taking insulin lispro since five years with humapen luxura half dose when she was diagnosed with diabetes (improper use of the device), humapen luxura half dose got impaired since (b)(6) 2020 (two-three months) as pen became heavy in its movement that it hurt her (product complaint (b)(4), lot unknown) and the needle becomes heavier with time and sprayed it with alcohol, the pen became even heavier since two days that it hurt and causing pain to her due to its heaviness on her leg.Approximately on (b)(6) 2020 (a week ago) she suffered from a hypoglycemic coma where her blood glucose level was in range of 23-24 mg/dl, but she recovered and did not go to hospital.The event of hypoglycemic coma was considered as serious by company due to its medically significance.Information regarding corrective treatment was not provided.Outcome of the event hypoglycemic coma was recovered.Outcome of the remaining events was unknown.Status of insulin lispro therapy was ongoing.The patient was the operator of the reusable humapen luxura half dose device and her training status was not provided.The general reusable humapen luxura half dose device model duration of use was unknown and suspect reusable humapen luxura half dose device duration of use was around five years as started about in 2015 (improper use of the device).No troubleshooting was performed due to unavailability of the suspect reusable humapen luxura half dose device.The status of suspect reusable humapen luxura half dose device was ongoing, and the return of suspect reusable humapen luxura half dose device was expected.The reporting consumer did not provide relatedness assessment between the events and insulin lispro drug.The reporting consumer did not provide relatedness between the event of hypoglycemic coma and humapen luxura half dose device and considered remaining events related to humapen luxura half dose device.Edit 26aug2020: updated medwatch and (b)(6) for expedited device reporting.No new information added.Edit 26aug2020: added unique identifier number for the suspect humapen luxura hd device 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 update statement(s) dated 17sep2020 in the b.5.Field.No further follow-up is planned.Evaluation summary: a female patient reported that her humapen luxura hd device "got impaired since (b)(6) 2020 as pen became heavy in its movement." she stated that the "needle becomes heavier with time and she sprayed it with alcohol, the pen became even heavier since two days that it hurt and causing pain to her due to its heaviness on her leg." the patient experienced hypoglycemic coma.The device was not returned to the manufacturer for investigation (batch unknown).Therefore, it could not be evaluated to confirm the complaint or presence of a malfunction.Malfunction unknown.All humapen luxura hd devices are assessed for injection screw travel at the end of the manufacturing process, thus ensuring device functionality with high probability.The patient reportedly used the device for 5 years.The core instructions for use state the humapen luxura hd has been designed to be used for up to three years after first use.The core instructions for use also states if any of the parts of your humapen luxura hd appear broken or damaged, do not use, and to always carry a spare insulin pen in case your pen is lost or damaged.The patient's narrative that the "needle becomes heavier with time" indicates a potential needle re-use, which would make injections more difficult and painful.The core instructions for use states to use a new needle for each injection.There is evidence of improper use.The patient used the device beyond its approved use life and continued to use the device after experiencing problems with it.It is unknown if these misuses are relevant to the event of hypoglycemic coma.If the patient reused needles as the narrative indicates, this misuse is likely relevant to the complaint; it is unknown if this is relevant to the event of hypoglycemic coma.

Event Description

Lilly case id: (b)(4).This report is associated with product complaint: (b)(4).This solicited case, reported by a consumer via patient support program (psp), concerned a 15 year old (at the time of initial report) female patient of unknown origin.Medical history and concomitant medications were not provided.The patient received insulin lispro (rdna origin) injections (humalog, 100 iu/ml) from a cartridge via a reusable humapen luxura half dose, with unknown dose and frequency, subcutaneously, for the treatment of diabetes mellitus, beginning on an unknown date 2015 (five years ago).Since a long time around (b)(6) 2020 (five to seven months) she had been suffering from swelling in her leg associated with dry skin and bluish color at the site of injection, one leg was different than the other as she always took her insulin usually in one place as it was more comfortable for her and did not cause pain for her.She had been taking insulin lispro since five years with humapen luxura half dose when she was diagnosed with diabetes (improper use of the device), humapen luxura half dose got impaired since (b)(6) 2020 (two to three months) as pen became heavy in its movement that it hurt her (product complaint (b)(4), lot unknown) and the needle becomes heavier with time and sprayed it with alcohol, the pen became even heavier since two days that it hurt and causing pain to her due to its heaviness on her leg.Approximately on (b)(6) 2020 (a week ago) she suffered from a hypoglycemic coma where her blood glucose level was in range of 23 to 24 mg/dl, but she recovered and did not go to hospital.The event of hypoglycemic coma was considered as serious by company due to its medically significance.Information regarding corrective treatment was not provided.Outcome of the event hypoglycemic coma was recovered.Outcome of the remaining events was unknown.Status of insulin lispro therapy was ongoing.The patient was the operator of the reusable humapen luxura half dose device and her training status was not provided.The general reusable humapen luxura half dose device model duration of use was unknown and suspect reusable humapen luxura half dose device duration of use was around five years as started about in 2015 (improper use of the device).No troubleshooting was performed due to unavailability of the suspect reusable humapen luxura half dose device.The status of suspect reusable humapen luxura half dose device was ongoing.The humapen luxura half dose device (unknown lot) associated with (b)(4) was not returned to the manufacturer.The reporting consumer did not provide relatedness assessment between the events and insulin lispro drug.The reporting consumer did not provide relatedness between the event of hypoglycemic coma and humapen luxura half dose device and considered remaining events related to humapen luxura half dose device.Edit 26aug2020: updated medwatch and european and canadian (eu/ca) fields for expedited device reporting.No new information added.Edit 26aug2020: added unique identifier number for the suspect humapen luxura hd device for expedited device reporting.No new information added.Update 17sep2020: additional information received on 17sep2020 from the global product complaint database.Entered device specific safety summary (dsss).Updated the medwatch fields with device information and the european and canadian (eu/ca) device information for the humapen luxura half dose device (unknown lot) associated with product complaint (b)(4) which was not returned to the manufacturer.Corresponding fields and narrative updated accordingly.

• Brand Name: HUMAPEN LUXURA HALF-DOSE PEN
• Type of Device: FOR TREATMENT PURPOSES
• Manufacturer (Section D): ELI LILLY AND COMPANY; lilly corporate center; indianapolis IN 46285
• MDR Report Key: 10459372
• MDR Text Key: 213692888
• Report Number: 1819470-2020-00111
• Device Sequence Number: 1
• Product Code: FMF
• UDI-Device Identifier: 00300029673019
• UDI-Public: 00300029673019
• Combination Product (y/n): N
• PMA/PMN Number: K100988
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,consum
• Type of Report: Initial,Followup
• Report Date: 09/23/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/27/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Model Number: MS9673A
• Device Catalogue Number: MS9673
• Was Device Available for Evaluation?: Yes
• Date Manufacturer Received: 09/17/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 15 YR