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

Model Number MS9673A

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

Patient Problem Hypoglycemia (1912)

Event Date 09/07/2019

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 report is associated with product compliant: (b)(4).This solicited case, reported by a consumer via a patient support program (psp), concerns a (b)(6)-year-old female patient of an unspecified origin.Medical history was not provided.Concomitant medications included insulin glargine (lantus) for an unspecified indication.The patient received insulin lispro (rdna origin) injection (humalog 100u/ml) cartridge via a reusable pen (humapen luxura half dose pen), three times daily, subcutaneously for the treatment of diabetes mellitus type i starting in (b)(6) 2018.Dose was not provided.On an unspecified date, but while taking insulin lispro her blood glucose was low at 57 or 67 mg/dl and approximately early (b)(6) 2019 her glycosylated hemoglobin (hb1ac) was 11.8 % (no reference values were provided).Furthermore, on (b)(6) 2019 her blood glucose level dropped to 38 mg/dl (no reference values were provided).Reportedly, her humapen luxura hd lenses was broken (pc: 4874669/ lot: 1201g07).The company considered the event of glucose level dropped to 38 mg/dl as serious due to its medical significance.Information regarding corrective treatment was not provided.On (b)(6) 2019 she fully recovered from the event of glucose level of 38 mg/dl.No hospitalization was required.The outcome of the remaining events was not provided.The treatment with insulin lispro was ongoing.The user of the humapen luxura hd and his/her training status was not provided.The general humapen luxura hd model duration of use was not provided, and the suspect humapen luxura hd duration of use was one year and five months as it was started in (b)(6) 2018.The suspect humapen luxura hd was ongoing, the return status of the suspect humapen luxura hd was not provided.The reporting consumer did not know if the event of glucose level dropped to 38 mg/dl was related to the treatment with insulin lispro or to the humapen luxura hd.The reporting consumer did not provide any other opinion of relatedness between events and insulin lispro treatment or humapen luxura hd device.Update 17-sep-2019: (b)(4) was received and added to the narrative.No other change was made.Edit 24sep2019: updated medwatch fields for expedited device reporting.No new information added.Edit 02oct2019: updated medwatch 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 dated 09oct2019 in the b.5.Field.No further follow-up is planned.Evaluation summary: the medical educator reported on behalf of a female patient that the lens of the patient's humapen luxura hd device was broken.The patient experienced decreased blood glucose levels.The device was not returned to the manufacturer for investigation (batch number 1201g07, manufactured january 2012).Therefore, it could not be evaluated to confirm the complaint or presence of a malfunction.Malfunction unknown.A complaint history review for the device batch did not identify any atypical findings with regard to lens broken or dose accuracy.There is no evidence of improper use or storage.

Event Description

Lilly case id: (b)(4).This solicited case, reported by a consumer via a patient support program (psp), concerns a 08-year-old female patient of an unspecified origin.Medical history was not provided.Concomitant medications included insulin glargine (lantus) for an unspecified indication.The patient received insulin lispro (rdna origin) injection (humalog 100u/ml) cartridge via a reusable pen (humapen luxura half dose pen), three times daily, subcutaneously for the treatment of diabetes mellitus type i starting in (b)(6) 2018.Dose was not provided.On an unspecified date, but while taking insulin lispro her blood glucose was low at 57 or 67 mg/dl and approximately early (b)(6) 2019 her glycosylated hemoglobin (hb1ac) was 11.8% (no reference values were provided).Furthermore, on (b)(6) 2019 her blood glucose level dropped to 38 mg/dl (no reference values were provided).Reportedly, her humapen luxura hd lenses was broken ((b)(4)/ lot: 1201g07).The company considered the event of glucose level dropped to 38 mg/dl as serious due to its medical significance.Information regarding corrective treatment was not provided.On (b)(6) 2019 she fully recovered from the event of glucose level of 38 mg/dl.No hospitalization was required.The outcome of the remaining events was not provided.The treatment with insulin lispro was ongoing.The user of the humapen luxura hd and his/her training status was not provided.The general humapen luxura hd model duration of use was not provided, and the suspect humapen luxura hd duration of use was one year and five months as it was started in (b)(6) 2018.The suspect humapen luxura hd was ongoing.The suspect humapen luxura hd device associated with product complaint (b)(4) was not returned to the manufacturer.The reporting consumer did not know if the event of glucose level dropped to 38 mg/dl was related to the treatment with insulin lispro or to the humapen luxura hd.The reporting consumer did not provide any other opinion of relatedness between events and insulin lispro treatment or humapen luxura hd device.Update 17-sep-2019: (b)(4) was received and added to the narrative.No other change was made.Edit 24sep2019: updated medwatch fields for expedited device reporting.No new information added.Edit 02oct2019: updated medwatch fields for expedited device reporting.No new information added.Update 09oct2019: additional information received on 09oct2019 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.Added date of manufacturer for the suspect humapen luxura hd device 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: 9167149
• MDR Text Key: 166668624
• Report Number: 1819470-2019-00171
• 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: 10/30/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/08/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Other
• Device Model Number: MS9673A
• Device Lot Number: 1201G07
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 10/09/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 8 YR