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

Model Number MS9673A

Device Problems Break (1069); Fracture (1260); Mechanical Jam (2983)

Patient Problems Hypoglycemia (1912); Syncope/Fainting (4411)

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 solicited case, reported by a consumer via a patient support program (psp), concerned a (b)(6) female patient of unknown origin.Medical history were not provided.Concomitant medications included navitron (as reported) for treatment of goitre.The patient received insulin lispro (rdna origin) injections (humalog) from cartridge, via a reusable pen (humapen luxura half-dose), at dose changing between 07 international units (iu) to 10 iu, sometimes additional dose changing between 03 iu-05 iu, three times in a day, via unknown route of administration, for treatment of diabetes mellitus, beginning on (b)(6) 2020.On an unknown date in spring almost (b)(6) 2020, after starting insulin lispro therapy, she fainted, her blood sugar level was almost 20 and serum inserted to her in hospital.It happened suddenly, she had tremor, her mouth locked and fainted.This incident was not related with application pen, she might be ate less.There was a plastic thing which was pushing the drug like an arrow, it was broken (pc: 5729949, lot number: 1808g01).There was no drop or damage in application pen.Black bar inside of application pen was jammed and broke on (b)(6) 2021 or (b)(6) 2021 (exact date was not provided).She was continuing to receive insulin with spare application pen.Her blood sugar level was unbalanced, it was either increasing and decreasing (second episode of blood sugar decreased).As of (b)(6) 2021 (at the time of initial report), there was no problem related blood sugar level.Outcome of events blood sugar increased and blood sugar decreased (second episode) was recovered.Further information regarding hospitalization, corrective treatment and outcome of remaining events was not provided.Insulin lispro therapy was continued.No follow would be attempted as reporter did not give consent for follow up procedures.The operator of the humapen luxura hd was the unknown and his/her training status was not provided.The humapen luxura hd general model duration of use was not provided and suspect humapen duration of use was approximately 17 months.Action taken with the suspect humapen luxura hd was discontinued and its return was expected.The initial reporting consumer did not provide the relatedness assessment of the events with insulin lispro drug.The initial reporting consumer did not provide relatedness assessment of the non-serious events of blood sugar increased and decreased with suspect humapen luxura hd device and did not relate the remaining events with suspect humapen luxura hd device.Update 29-sep-2021: all information received on 23-sep-2021 and 26-sep-2021 were processed together.Edit 13oct2021: updated medwatch and european and (b)(6) (eu/(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 update statement(s) dated 11nov2021 in the b.5.Field.No further follow-up is planned.Evaluation summary: the father of a female patient reported that the injection screw of the patient's humapen luxura hd device was jammed and broke on (b)(6) 2021.In (b)(6) 2020, the patient experienced syncope and decreased blood glucose.The device was not returned to the manufacturer for investigation (batch 1808g01, manufactured august 2018).Therefore, it could not be evaluated to confirm the complaint or presence of a malfunction.Malfunction unknown.A complaint history review did not identify any atypical findings with regard to broken injection screw issues.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.There is no evidence of improper use or storage.

Event Description

Lilly case id: (b)(4).This report is associated with product complaint: (b)(4).This solicited case, reported by a consumer via a patient support program (psp), concerned a 09-year-old female patient of unknown origin.Medical history were not provided.Concomitant medications included navitron (as reported) for treatment of goitre.The patient received insulin lispro (rdna origin) injections (humalog) from cartridge, via a reusable pen (humapen luxura half-dose), at dose changing between 07 international units (iu) to 10 iu, sometimes additional dose changing between 03 iu-05 iu, three times in a day, via unknown route of administration, for treatment of diabetes mellitus, beginning on (b)(6) 2020.On an unknown date in spring almost (b)(6) 2020, after starting insulin lispro therapy, she fainted, her blood sugar level was almost 20 and serum inserted to her in hospital.It happened suddenly, she had tremor, her mouth locked and fainted.This incident was not related with application pen, she might be ate less.There was a plastic thing which was pushing the drug like an arrow, it was broken (pc: (b)(4), lot number: 1808g01).There was no drop or damage in application pen.Black bar inside of application pen was jammed and broke on (b)(6) 2021 (exact date was not provided).She was continuing to receive insulin with spare application pen.Her blood sugar level was unbalanced, it was either increasing and decreasing (second episode of blood sugar decreased).As of (b)(6) 2021 (at the time of initial report), there was no problem related blood sugar level.Outcome of events blood sugar increased and blood sugar decreased (second episode) was recovered.Further information regarding hospitalization, corrective treatment and outcome of remaining events was not provided.Insulin lispro therapy was continued.No follow would be attempted as reporter did not give consent for follow up procedures.The operator of the humapen luxura hd was the unknown and his/her training status was not provided.The humapen luxura hd general model duration of use was not provided and suspect humapen duration of use was approximately 17 months.Action taken with the suspect humapen luxura hd was discontinued.The device was returned to manufacturer.The initial reporting consumer did not provide the relatedness assessment of the events with insulin lispro drug.The initial reporting consumer did not provide relatedness assessment of the non-serious events of blood sugar increased and decreased with suspect humapen luxura hd device and did not relate the remaining events with suspect humapen luxura hd device.Update 29-sep-2021: all information received on 23-sep-2021 and 26-sep-2021 were processed together.Edit (b)(6) 2021: updated medwatch and european and canadian (eu/ca) fields for expedited device reporting.No new information added.Update 10nov2021: additional information received on 09nov2021 from the global product complaint database.Entered the device specific safety summary (dsss); updated the medwatch and european and canadian (eu/ca) device fields and device return status to returned to manufacturer; and added date of manufacture and added date returned to manufacturer for the suspect device with pc (b)(4) associated with (b)(4).Corresponding fields and narrative updated accordingly.Edit 02dec2021: updated medwatch fields.No new information added.

Event Description

Lilly case id: (b)(4).This report is associated with product complaint: (b)(4).This solicited case, reported by a consumer via a patient support program (psp), concerned a 09-year-old female patient of unknown origin.Medical history were not provided.Concomitant medications included navitron (as reported) for treatment of goitre.The patient received insulin lispro (rdna origin) injections (humalog) from cartridge, via a reusable pen (humapen luxura half-dose), at dose changing between 07 international units (iu) to 10 iu, sometimes additional dose changing between 03 iu-05 iu, three times in a day, via unknown route of administration, for treatment of diabetes mellitus, beginning on (b)(6) 2020.On an unknown date in spring almost (b)(6) 2020, after starting insulin lispro therapy, she fainted, her blood sugar level was almost 20 and serum inserted to her in hospital.It happened suddenly, she had tremor, her mouth locked and fainted.This incident was not related with application pen, she might be ate less.There was a plastic thing which was pushing the drug like an arrow, it was broken (pc: (b)(4), lot number: 1808g01).There was no drop or damage in application pen.Black bar inside of application pen was jammed and broke on (b)(6) 2021 or (b)(6) 2021 (exact date was not provided).She was continuing to receive insulin with spare application pen.Her blood sugar level was unbalanced, it was either increasing and decreasing (second episode of blood sugar decreased).As of (b)(6) 2021 (at the time of initial report), there was no problem related blood sugar level.Outcome of events blood sugar increased and blood sugar decreased (second episode) was recovered.Further information regarding hospitalization, corrective treatment and outcome of remaining events was not provided.Insulin lispro therapy was continued.No follow would be attempted as reporter did not give consent for follow up procedures.The operator of the humapen luxura hd was the unknown and his/her training status was not provided.The humapen luxura hd general model duration of use was not provided and suspect humapen duration of use was approximately 17 months.Action taken with the suspect humapen luxura hd was discontinued.The suspect humapen luxura hd device associated with (b)(4) (lot 1808g01) was returned to the manufacturer on 09nov2021 of which tool marks were noted above the break point (evidence of improper use).The initial reporting consumer did not provide the relatedness assessment of the events with insulin lispro drug.The initial reporting consumer did not provide relatedness assessment of the non-serious events of blood sugar increased and decreased with suspect humapen luxura hd device and did not relate the remaining events with suspect humapen luxura hd device.Update 29-sep-2021: all information received on 23-sep-2021 and 26-sep-2021 were processed together.Edit 13oct2021: updated medwatch and european and canadian (eu/ca) fields for expedited device reporting.No new information added.Update 10nov2021: additional information received on 09nov2021 from the global product complaint database.Entered the device specific safety summary (dsss); updated the medwatch and european and canadian (eu/ca) device fields and device return status to returned to manufacturer; and added date of manufacture and added date returned to manufacturer for the suspect device with (b)(4) associated with 1808g01.Corresponding fields and narrative updated accordingly.Edit 02dec2021: updated medwatch fields.No new information added.Update 13dec2021: additional information received on 08dec2021 from the global product complaint database.Updated the device specific safety summary (dsss), the medwatch device fields, improper use and storage from no to yes, malfunction from unknown to yes for the suspect humapen luxura hd 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 update statement(s) dated 13dec2021 in the b.5.Field.No further follow-up is planned.Evaluation summary the father of a female patient reported that the injection screw of the patient's humapen luxura hd device was jammed and broke on (b)(6) 2021 or (b)(6) 2021.In (b)(6) 2020, the patient experienced syncope and decreased blood glucose.The investigation of the returned device (batch 1808g01, manufactured august 2018) found the injection screw was broken, rendering the device non-functional.Malfunction confirmed.The damage to the injection screw indicates the device was damaged while in the field, as evidenced by tool marks above the break point.This type of damage would have been detected during the manufacturing inspection process.The core instructions for use state to not use the device if it appears broken or damaged and to contact lilly or a healthcare professional for a replacement pen.There is evidence of improper use.The damage to the device occurred while in the field (not related to the manufacturing process).This misuse is not likely relevant to the events of syncope and decreased blood glucose which occurred one and a half years prior to the breakage.

• 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
• Manufacturer (Section G): PHILLIPS-MEDISIZE CORPORATION; medical device manufacturing; 415 red cedar street; menomonie WI 54751
• Manufacturer Contact: chris davis ; lilly corporate center; indianapolis, IN 46285 ; 3174334585
• MDR Report Key: 12633172
• MDR Text Key: 281677719
• Report Number: 1819470-2021-00137
• Device Sequence Number: 1
• Product Code: FMF
• UDI-Device Identifier: 00300029673019
• UDI-Public: 00300029673019
• Combination Product (y/n): N
• Reporter Country Code: TU
• PMA/PMN Number: K100988
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Study,Consumer,Company Representative
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup,Followup
• Report Date: 01/05/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/14/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Other
• Device Model Number: MS9673A
• Device Catalogue Number: MS9673
• Device Lot Number: 1808G01
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 11/09/2021
• Date Manufacturer Received: 12/08/2021
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 08/31/2018
• 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
• Patient Outcome(s): Hospitalization
• Patient Age: 9 YR
• Patient Sex: Female